Browse By Topic: Clinical Trials

New Research: Two Potential Treatments for Dry Macular Degeneration and Geographic Atrophy

A retina with dry AMD One of the most significant challenges facing eye and vision researchers is developing an effective treatment for dry age-related macular degeneration (AMD). Although there are a number of well-regarded FDA-approved drug treatments for wet AMD, the key to effective dry AMD treatment continues to be elusive.


The FDA Officially Cracks Down on Stem Cell Clinics Offering Unproven and Dangerous Treatments

On Monday, August 28, 2017, Scott Gottlieb, M.D., Commissioner of the United States Food and Drug Administration (FDA), announced a crackdown on stem cell clinics offering unproven and potentially dangerous treatments. Commissioner Gottlieb stated that he "will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work." You can read Dr. Gottlieb's full stem cell statement at Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA's new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative


Readers Beware: Are All Clinical Trials Legitimate? Learn What to Look for and How to Protect Yourself

A retina with wet AMD Of all the eye research developments reported on the VisionAware blog, it is stem cell research for eye disease that generates the most inquiries from our readers. Many readers request information about stem cells, assuming that this is an established and widely-performed treatment for eye disease; others ask for help in finding a doctor who will administer "stem cell treatments." In response to these inquiries, my message is always the same: "Although stem cell research for eye disease has produced a small number of interesting results, it is in its very earliest safety-testing


The Reality and Costs of Gene Therapy for Eye Disease: Who Will (or Can) Pay?

As our readers know, VisionAware is committed to providing current and reliable information about eye and vision research that is relevant to adults and older adults, many of whom experience late-life vision loss resulting in low vision. During the past several years, gene therapy has gained traction and offers promise for treating (but not yet curing) a range of eye diseases, including retinitis pigmentosa,


Treating Macular Degeneration with Gene Therapy: New Research Shows Promise but Also Has Limitations

The Lancet logo Currently, there are a number of treatments for wet age-related macular degeneration, including the drugs Lucentis, Eylea, and Avastin, administered by injection with a very small needle directly into the eye after the surface has been numbed (also called


The FDA Approves Lucentis for the Treatment of Diabetic Retinopathy

A retina with diabeticretinopathy On April 17, 2017, the United States Food and Drug Administration (FDA) granted approval to the injectable drug Lucentis (generic name ranibizumab) for the treatment of proliferative diabetic retinopathy (PDR), a serious vision-related complication of diabetes. Previously, the FDA approved Lucentis for the treatment of diabetic


Readers Beware: In a Dangerous and Unregulated Stem Cell Treatment, Patients Lose Sight After Stem Cells Are Injected Into Their Eyes

A retina with wet AMD Of all the eye research developments reported on the VisionAware blog, it is stem cell research for eye disease that generates the most inquiries from our readers. Many readers request information about stem cells, assuming that this is an established and widely-performed treatment for eye disease; others ask for help in finding a doctor who will administer "stem cell treatments." In response to these inquiries, my message is always the same: "Although stem cell research for eye disease has produced a small number of interesting results, it is in its very earliest safety-testing


Clinical Trial Update: Squalamine Eye Drops for Wet Macular Degeneration

A retina with wet AMD Many readers have been following closely the development of Squalamine Eye Drops for wet age-related macular degeneration, hoping that a self-administered at-home eye drop could reduce, or even eliminate, the need for monthly or as-needed eye injections. Unfortunately, a clinical trial designed to test this concept has produced disappointing results: Squalamine Eye Drops failed to reduce the average number of


Our Readers Want to Know: What Is the Progress of Stem Cell Research for Eye Disease? Answer: It Has a Very Long Way to Go

Logo of the Association forResearch in Vision andOphthalmology Of all the eye research developments reported on the VisionAware blog, it is stem cell research for eye disease that generates the most inquiries from readers. Many readers request information about how to join a stem cell clinical trial, or find a doctor who will perform stem cell treatments. In response to these inquiries, my message is always the same: "Although stem cell research has produced interesting results, it is in its very earliest stages and must be subjected to additional, longer-term, rigorous study and clinical trials, encompassing many more years of research. Success in this


Clinical Trial Update: An Unsuccessful Trial of Combination Drugs Fovista and Lucentis for Macular Degeneration

A retina with wet AMD Although the advent of anti-VEGF therapy (explained below), administered via eye injection with Lucentis, Eylea, or Avastin, has revolutionized the treatment of wet age-related macular degeneration (AMD), there are still a


New and Ongoing Research: A Drug-Dispensing Contact Lens that Effectively Lowers Eye Pressure Associated with Glaucoma

Several recent eye research projects have addressed the potential of contact lenses as a way to (a) deliver ocular drugs directly to the eye, (b) measure blood glucose levels, and (c) monitor intraocular (within the eye) pressure. Two prominent examples are the FDA-approved Triggerfish contact lens, which monitors intraocular pressure related to glaucoma, and


Updates from the London Project to Cure Blindness: Stem Cell Research for Wet and Dry Macular Degeneration

Please note: This is an older post and there have significant challenges in stem cell research for eye disease since this was published. For more current information, see Our Readers Want to Know: What Is the Progress of Stem Cell Research for Eye Disease? Answer: It Has a Very Long Way to Go. The London Project to Cure Blindness was established ten years ago in the United Kingdom with the goal of


New Research Indicates Long-Term Positive Effects of Intensive Blood Sugar Control on the Progression of Diabetic Retinopathy

New diabetes and diabetic retinopathy research indicates that people with type 2 diabetes, who intensively controlled their blood sugar levels during the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial Eye Study, cut their risk of diabetic retinopathy in half in a follow-up analysis, called the ACCORD Follow-on


Our Readers Want to Know: Can You Tell Me More About Nutritional Supplements for Age-Related Macular Degeneration?

Editor's note: One of the many benefits associated with an online information center and website, such as VisionAware, is the ability to track readers' search terms [i.e., information readers are seeking as they search the Internet] as well as answer specific reader inquiries via email. Every month, questions about macular degeneration (AMD), including risks, treatments, and helpful resources, consistently rank among the top inquiries: I am 76 years old and have dry AMD in my left eye and wet in the other, first diagnosed in 2009. Can supplements help me or am I wasting my money? I am currently using [a pharmacy


The FDA Approves Marketing of the Triggerfish "Smart" Contact Lens Sensor to Monitor Glaucoma Eye Pressure

On March 4, 2016, the United States Food and Drug Administration (FDA) announced that it would allow the marketing of the Triggerfish® Sensor, a "smart" contact lens that may help eye doctors identify the best time of day to measure a patient's intraocular [i.e., within the eye] pressure, or IOP. Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma. The FDA granted this approval via the


New Research: Statins May Show Promise as a Treatment for Dry Age-Related Macular Degeneration

One of the most significant challenges facing eye and vision researchers is developing an effective treatment for dry age-related macular degeneration (AMD). Although there are now a number of well-regarded FDA-approved drug treatments for wet AMD, the key to effective dry AMD treatment remains elusive, although


Meet Author Irv Arons and Learn More About Gene Therapy and Gene Editing for Eye Disease

Irv Arons is the creator of – and driving force behind – Irv Arons' Journal, an online compendium of the latest information on ophthalmics, medical lasers, clinical trials, developments in stem cell therapy and gene therapy, and emerging drug therapies and treatments for retinal diseases, including age-related macular degeneration. Until his retirement in 2005, Irv was a consultant to the ophthalmic industry for over 30 years, and to the medical laser industry for over 20 years.


Meet Dr. Gislin Dagnelie and Dr. Duane Geruschat: Pioneers in the Study of Restored and Prosthetic Vision

Gislin Dagnelie, Ph.D., is an Associate Professor of Ophthalmology in the Johns Hopkins University School of Medicine and the associate director of the Lions Vision Research and Rehabilitation Center, a division of the Johns Hopkins Wilmer Eye Institute. His work over the last 20 years has been supported by grants from the National Institutes of Health, National Science Foundation,


New Research Explained: Restoring Vision Following Long-Term Blindness: Prosthetic Vision and Considerations for Rehabilitation

During the past several years, there has been much "buzz" in the popular press about the capabilities of the so-called "bionic" eye, described variously as "miraculous," "restoring sight," and "letting me see again." At VisionAware, we have followed the development of "bionic" or "prosthetic" vision closely, avoiding hyperbole and striving to report factual, research-based information about the limitations of restored vision. Now, in this month's edition of the Journal of Vision Impairment & Blindness, two researchers who are pioneers in the study of prosthetic vision analyze the current state of the art in


New Genetic Research in Macular Degeneration: The International AMD Genomics Consortium

The International Age-Related Macular Degeneration (AMD) Genomics Consortium, which includes 26 centers worldwide, has published new data and information about the role of genes and their contribution to the risk of macular degeneration. Previously, researchers had identified 21 regions of the human genome – called loci – that are associated with an increased risk of AMD. The new research, published in Nature Genetics, increases the number of loci to 34.


New Research: Gene Therapy Restores Some Vision in Clinical Trials for Leber Congenital Amaurosis (LCA)

Gene therapy for the treatment of specific eye and retinal disorders, such as Leber congenital amaurosis (LCA), has shown promise, but research has produced uneven results thus far and has not produced a cure. To date, gene therapy studies have raised concerns among researchers, including inconsistent initial and longer-term results, such as this LCA gene therapy study from the National Eye Institute, which reported that


New Research: Lucentis Is Effective in Treating Proliferative Diabetic Retinopathy and More Effective than Traditional Laser Treatment

Results from a new clinical trial have revealed that the injectable drug Lucentis is highly effective in treating proliferative diabetic retinopathy, a serious vision-related complication of diabetes. "These findings," said Dr. Paul Sieving, Director of the National Eye Institute (NEI), "provide crucial evidence for a safe and effective alternative to laser


New Macular Degeneration Research: Some Eyes not Responsive to Initial Eye Injection Treatments May Benefit from Continued Treatment without Switching Drugs

Although the advent of anti-VEGF therapy (also called eye injections, explained below) has revolutionized the treatment of wet age-related macular degeneration (AMD), there are still a number of persons – although in the minority – who do not respond to treatment. It is these "non-responders" or "reduced responders" who continue to pose significant challenges to doctors and researchers. Since there are not, at present, specific protocols that govern ophthalmologists' decisions to switch


Enrollment News about the New PIVOT Study: Patient-centric Innovative Vision Home Testing

The PIVOT Study (Patient-centric Innovative Vision HOme Testing) is a new clinical study that is being initiated to determine if persons with diabetic macular edema (DME) or wet age-related macular degeneration (wet AMD) can use the myVisionTrack™ (mVT™) mobile medical application (also called


The First Stem Cell Clinical Trial for Wet Macular Degeneration Is Underway in London

Please note: This is an older post and there have been setbacks and significant changes in stem cell research for eye disease since this was first published. For more current information, see Our Readers Want to Know: What Is the Progress of Stem Cell Research for Eye Disease? Answer: It Has a Very Long Way to Go. Also see the author's updates in the comment section below. A pioneering clinical trial of a new treatment derived from embryonic


New Retinitis Pigmentosa Research: Uncovering the Mechanism Underlying Photoreceptor Cell Death

Researchers from the National Eye Institute and New York University have published new research that implicates the normally beneficial and protective "trash-collecting" central nervous system cells in the accelerated cell death associated with retinitis pigmentosa. Please note that this research is in its earliest stages and has been conducted thus far only with laboratory mice. However, a new clinical trial related to this study, Oral Minocycline in Treating Bilateral Cystoid Macular Edema


New Research: The Argus II Retinal Prosthesis (Bionic Eye) Is Safe, Effective, and Improves Visual Function

New clinical trial results from the Argus II Study Group, an international consortium of eye and vision researchers, confirm that the Argus II, also called the "bionic eye," is a safe, reliable, and effective device that "significantly improves visual function and quality of life for people blinded by retinitis pigmentosa." The latest research, entitled Long-Term Results from an Epiretinal [i.e, "on," "upon," "near," or "against" the retina] Prosthesis


Optogenetics: Can This Innovative Gene Therapy Treat Degenerative Retinal Disease and Possibly Restore Sight?

A research group of Swiss and German scientists has restored vision to mice with a condition similar to retinitis pigmentosa (RP) by introducing engineered light-sensing proteins into their eyes, via a process known as optogenetics. Optogenetics is a still-experimental treatment for a variety of blinding retinal disorders that uses gene therapy to enable retinal and brain cells to respond to light. According to the researchers, "… optogenetic gene therapy, which selectively introduces genes encoding light-sensitive proteins into surviving retinal cells to act as


New Glaucoma Research from the UK: Eye Pressure-Lowering Drops Can Help Preserve the Visual Field

The most commonly prescribed medication for the treatment of open-angle glaucoma is a class of eye pressure-lowering drugs called prostaglandin analogues (explained below). Until recently, however, the extent to which these drugs could help preserve the visual field and protect visual function had not been assessed via controlled clinical trials. The United Kingdom Glaucoma Treatment Study, which examined this question via a


New Research: Top-Selling Eye Supplements Lack Scientific Evidence, Make Unsupported Claims

An American research group has concluded that claims made about top-selling eye vitamin brands and products in the United States lack concrete scientific evidence supported by clinical trial outcomes. The researchers also determined that many of the most heavily promoted and top-selling products do not contain ingredients and dosages identical to "eye vitamin" formulas that have been proven effective in the Age-Related Eye Disease Studies (AREDS and AREDS2), sponsored by the National Eye


Existing FDA-Approved HIV/AIDS Drugs Could Be Repurposed to Treat Macular Degeneration

An international research group has reported that HIV/AIDS drugs, in use for the last 30 years, could be repurposed to treat age-related macular degeneration (AMD), as well as other systemic inflammatory disorders. Their research tested the treatment effects of nucleoside reverse transcriptase inhibitors (NRTIs) on dry AMD in laboratory mice. NRTIs are a class of drugs that were designed to


Adult Stem Cells for Dry AMD: Emerging Future Research from the National Eye Institute

One of the most significant challenges facing eye and vision researchers is the development of an effective treatment for dry age-related macular degeneration (AMD). Although there are now a number of well-regarded FDA-approved drug treatments for wet AMD, the key to effective dry AMD treatment remains elusive thus far, although


Updated Stem Cell Clinical Trial Results for Stargardt Disease and Dry Macular Degeneration

Please note: this is an older post and much has changed since the time of publication. For more current information, see Our Readers Want to Know: What Is the Progress of Stem Cell Research for Eye Disease? Answer: It Has a Very Long Way to Go. Also see the author's updates, below. On October 14, 2014, Ocata Therapeutics (formerly Advanced Cell Technology, Inc.) announced positive


The FDA Approves Injectable Implant ILUVIEN for Treatment of Diabetic Macular Edema

On September 26, 2014, Alimera Sciences, Inc. announced that the United States Food and Drug Administration (FDA) approved Iluvien for the treatment of diabetic macular edema in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Alimera Sciences, Inc., headquartered in Alpharetta,


In Clinical Trials: A Potential Self-Administered Treatment for Diabetic Macular Edema

Aerpio Therapeutics, Inc. is a new Cincinnati, Ohio-based biopharmaceutical company focused on developing new therapies for vascular [i.e., blood vessel] diseases, including diabetic macular edema (DME) and age-related macular degeneration (AMD). This week, Aerpio announced positive clinical trial results for


The FDA Approves EYLEA Injection for the Treatment of Diabetic Macular Edema

Some good news for individuals who have diabetes and associated diabetic macular edema: On July 29, 2014, the United States Food and Drug Administration (FDA) approved EYLEA (generic name aflibercept) for the treatment of diabetic macular edema. The recommended dosage is two milligrams (mg) every two


Alzheimer Research: Cataract Surgery for People with Dementia Improves Vision and Quality of Life

Results from a new clinical trial, presented at the July 2014 Alzheimer's Association International Conference, suggest that cataract surgery may slow mental decline in people with Alzheimer's disease and related dementias. Preliminary study results indicate that improved vision, resulting from cataract surgery, can have a variety of benefits – both visual and non-visual – for people with dementia. The


Integrated Low Vision and Mental Health Treatment Can Reduce or Prevent Depression

The first clinical trial to examine integrated low vision and mental health treatment – bridging ophthalmology, optometry, psychiatry, psychology, and rehabilitation – has demonstrated that an interdisciplinary rehabilitation program can reduce the incidence of depression by half among older adults with low vision due to age-related macular degeneration (AMD). Ophthalmology: the Journal The research, entitled Low Vision Depression Prevention Trial in Age-Related Macular


What Is Visual Ability? A New Study Looks at Low Vision Rehabilitation

Researchers associated with the Low Vision Research Network Study Group have identified a number of non-visual factors that can affect "visual ability" [i.e., a person's ability to perform everyday tasks that are dependent on vision] in a group of older adults participating in outpatient low vision rehabilitation. The study concludes that visual ability is an individualized "multidimensional construct" that includes a number of interrelated visual and non-visual factors, such as visual acuity, mobility, physical ability, depression measures, and cognition (thinking, understanding, learning, and remembering). In addition, the researchers note that the


New Research: An Innovative Simulator Evaluates Eye Diseases and Driving Performance

The University of California, San Diego School of Medicine is the first ophthalmology department in the country to feature a fully dedicated, high-fidelity, realistic driving simulator to evaluate the effects of visual impairment, such as glaucoma and macular degeneration, on an individual's driving performance. The UC San Diego driving simulatorSource: UC San Diego Health System Newsroom Located in the Visual Performance Laboratory of the


Is It Possible that Glaucoma Is a Brain Disease?

A group of American and Australian researchers is proposing that glaucoma may actually be a brain – not an eye – disease. Their research theorizes that it is the brain, not the eye, controlling the cellular process that results in glaucoma. The study, entitled Refined Data Analysis Provides Clinical Evidence for Central Nervous System Control of Chronic Glaucomatous Neurodegeneration, was published in the May 2014 issue of Translational Vision Science & Technology.


Meet Duane Geruschat, Ph.D. and the Argus II Retinal Prosthesis at Second Sight Medical Products

Duane Geruschat, Ph.D. specializes in rehabilitation research with persons who are blind and visually impaired. His primary interest is in low vision orientation and mobility. He is a certified orientation and mobility specialist (COMS) and a certified low vision therapist (CLVT). Dr. Geruschat began his career working at a school for children with multiple disabilities and


Optogenetics: The Next Frontier in Vision Research? The Foundation Fighting Blindness Explains

June is Vision Research Month – a perfect time to highlight the innovative, cutting-edge research programs of the Foundation Fighting Blindness, headquartered in Columbia, Maryland. The urgent mission of the Foundation is to drive the research that will provide preventions, treatments, and cures for people affected by retinitis pigmentosa, macular degeneration,


New Research: Rethinking Charles Bonnet Syndrome and Visual Hallucinations

Charles Bonnet ("Bo-NAY") Syndrome (CBS) is a condition that causes vivid, complex, recurrent visual hallucinations, usually in older adults with later-life vision loss from eye conditions that can include macular degeneration, diabetic retinopathy, and glaucoma. The visual hallucinations associated with CBS can range from animated, colorful, dreamlike images to less complicated


Is a "Treat and Extend" Injection Regimen More Beneficial for Wet Macular Degeneration?

The treatment of wet age-related macular degeneration (AMD) has – by all accounts – been revolutionized by the successful use of the injectable drugs Eylea, Lucentis, and Avastin. Yet, despite this treatment revolution, significant questions remain about the most effective dosing schedule for these medications: Is it monthly injections, a pro re nata [i.e., "as


New Research: Are Lucentis, Avastin, and Eylea Risk Factors for Increased Eye Pressure?

The injectable drugs Eylea, Lucentis, and Avastin have revolutionized the treatment of wet age-related macular degeneration (AMD). Nevertheless, questions continue to arise regarding the risks and complications that accompany this delivery system. At present, these drugs require monthly injections or a pro re nata [i.e.,


Why Do Some People Not Respond to Eye Injections for Macular Degeneration?

Although the advent of anti-VEGF therapy (explained below) has revolutionized the treatment of wet age-related macular degeneration (AMD), there are still a number of persons – although in the minority – who do not respond to treatment. It is these "non-responders" or "reduced responders" who continue to pose significant challenges to clinicians and researchers. Recently, a team of Japanese researchers attempted to identify a number of factors that could (a) predict non-response to intravitreal [i.e., into the eye] injections of Lucentis for wet AMD and (b) establish criteria


Maintaining a Glaucoma Medication Regimen: What Factors Do – or Don't – Promote Adherence?

A critical component of glaucoma care, and one that physicians continuously stress, is the importance of adhering to a therapeutic eye drop regimen for glaucoma. In order for the medication to lower intraocular pressure effectively, consistent adherence to the prescribed eye drop regimen is essential. Yet, by most accounts, non-adherence – both intentional and unintentional – remains problematic. Barriers to adherence include the asymptomatic nature [i.e., exhibiting no


A Continuing Clinical Trial for Dry Age-Related Macular Degeneration

One of the most significant challenges facing eye and vision researchers is the development of an effective treatment for dry age-related macular degeneration (AMD). Although there are now a number of well-regarded FDA-approved drug treatments for wet AMD, the key to effective dry AMD treatment remains elusive. Current treatments for dry AMD include a number of non-drug-related measures, including (a) nutritional supplements recommended by the Age-Related Eye Disease


Surprising New Research from the National Eye Institute on Surgical Options for Congenital Cataracts

For adults who undergo cataract surgery, implantation of an artificial lens, also called an intraocular [i.e., within the eye] lens, or IOL, has been the standard of care for many years. However, an ongoing clinical trial, sponsored in part by the National Eye Institute, suggests that for many infants, surgery followed by the use of contact lenses for several years – and an eventual lens implant – may be a better solution. The research, entitled


Vanda Receives FDA Approval for Hetlioz, First Drug to Regulate Sleep Patterns of Blind People

On January 31, 2014, Vanda Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Hetlioz™ (tasimelteon) 20 mg. capsules for the treatment of "Non-24-Hour Sleep-Wake Disorder" (Non-24). Hetlioz is the first FDA-approved medication for Non-24. Non-24-Hour Sleep-Wake Disorder (Non-24) is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot reset their master body clocks to the 24-hour day. In the United States, this disorder affects approximately 80,000 totally blind individuals who lack the light sensitivity necessary to


Can Gene Therapy Provide a Cure for Retinal Disease? An Early-Stage Clinical Trial Says "Maybe"

A group of international researchers from the United Kingdom, the United States, the Netherlands, and Portugal have used gene therapy in a clinical trial to treat a small group of male subjects with choroideremia, a rare degenerative eye disease. This early-stage clinical trial demonstrates potential for the use of gene therapy to treat a number of additional retinal diseases, including age-related macular degeneration. The research, entitled Retinal gene therapy in patients with choroideremia: initial


A Home Monitoring Program for Age-Related Macular Degeneration: the ForeseeHome

The results of the HOme Monitoring of the Eye study, a subset of the Age-Related Eye Disease Study 2 (AREDS2), were presented last week at the Annual Meeting of the American Academy of Ophthalmology (AAO) in New Orleans, Louisiana, November 16-19, 2013. The study revealed that participants at high risk for developing wet (or neovascular) age-related macular degeneration (AMD) who used the ForeseeHome AMD


New Research Targets a Potential Cause of Dry Age-Related Macular Degeneration

A consortium of research groups from Finland, Italy, Germany, Hungary, and Saudi Arabia have provided laboratory evidence (via cell cultures and human tissue samples) that the degenerative changes characterizing age-related macular degeneration (AMD) – specifically dry AMD, for which there is no current treatment or cure – are caused by impaired function of the body's cellular "digestion" and "clean-up" mechanism, called autophagy, in the retina. Autophagy, a basic biological and metabolic process, "self-eats" cellular


The Argus II Retinal Prosthesis ("Bionic Eye") Receives Medicare Approval

On August 15, 2013, Second Sight Medical Products, Inc. announced that its Argus® II Retinal Prosthesis System has been approved by the Centers for Medicare and Medicaid Services (CMS) for both a new technology add-on payment (inpatient setting of care) and a transitional pass through payment (outpatient setting of care) beginning October 1, 2013. You can read the complete announcement at the Second Sight website. The Argus II Implantation Centers In July, Second Sight Medical Products,


In Spain, Researchers Regenerate Retina in Mice: the Laboratory Results

Recently, I learned about a fascinating study in which researchers from the Center for Genomic Regulation (CRG) in Barcelona, Spain have identified a pathway that triggers the reprogramming and regeneration of retinal neurons in the eye; in addition, they have regenerated mouse retinal tissue through cell reprogramming This research is in its earliest stages and has been conducted only with laboratory mice. Nevertheless, the concept shows great promise for persons with retinal disease. The study, entitled


The Argus II Retinal Prosthesis ("Bionic Eye") to Be Offered in 12 US Implantation Centers

Second Sight Medical Products, Inc., of Sylmar, California, has announced that its Argus® II Retinal Prosthesis System, also called the "artificial retina" or "bionic eye," will be offered in 12 implantation centers across the United States to treat patients with severe to profound retinitis pigmentosa (RP). The mission of Second Sight is to "develop, manufacture, and market implantable visual prosthetics to enable blind individuals to achieve greater independence."


New Research: Contact Lenses with a Built-In Telescopic Zoom for Macular Degeneration

Information about a new contact lens device, now in development (although not yet in clinical trials), that may benefit people with macular degeneration has been published in the July 1, 2013 issue of Optics Express. Optics Express, the international online journal of optics, is an all-electronic, open-access journal that publishes peer-reviewed articles emphasizing scientific and technological innovations in all aspects of optics and photonics. About the Contact Lens


Eylea May Help When Patients Do not Respond to Lucentis or Avastin for Macular Degeneration

A new study, published "online first" on May 23, 2013 in the American Journal of Ophthalmology, concludes that Eylea therapy appears to be beneficial in a specific group of patients with wet age-related macular degeneration (AMD) whose symptoms are not responsive to either Lucentis or Avastin injections. The


New Report: Dietary Supplements (AREDS Vitamins) and Their Effect on Macular Degeneration

A highly-anticipated study, published "online first" in the May 2013 issue of The Journal of the American Medical Association has concluded that adding omega-3 fatty acids (such as those found in fish oil) had no effect on the formulation, while the addition of lutein and zeaxanthin together appeared to offer a safe and effective alternative to the beta-carotene that was contained in the original AREDS formulation) commonly recommended for the treatment of age-related macular degeneration


Updates on the Progress of Clinical Trials for a Retinal Implant for Retinitis Pigmentosa

An updated study, entitled Artificial vision with wirelessly powered subretinal electronic implant has been published online in the February 2013 issue of Proceedings of the Royal Society B: Biological Sciences. Proceedings B is the Royal Society's biological research journal, dedicated to the rapid publication of high-quality research papers. The paper summarizes the results of a nine-subject clinical trial of a functional retinal implant for patients with


Low Vision Rehabilitation for Persons with Macular Degeneration and Mild Cognitive Deficits

A new study, published "online first" in the April 2013 issue of JAMA Ophthalmology (formerly Archives of Ophthalmology), demonstrates the feasibility and benefits of a low vision rehabilitation program for patients with macular disease who also have mild cognitive deficits. JAMA Ophthalmology is an international peer-reviewed journal published monthly by the American Medical Association (AMA), and is part of the


In Europe, a New Radiation Therapy for Wet Macular Degeneration Reduces Need for Lucentis Injections

Oraya Therapeutics, Inc. has released the results of its INTREPID clinical trial evaluating the safety and effectiveness of Oraya Therapy Stereotactic Radiotherapy for the treatment of wet age-related macular degeneration (AMD). The results indicate that a single dose of Oraya Therapy significantly reduces the need for Lucentis injections in persons with wet AMD, with


Developments in Stem Cell Therapy for Macular Disease

Since November 2010, I have been following Advanced Cell Technology's (ACT) quest to implement successful clinical trials for macular eye disease, using human embryonic stem cells. ACT's U.S. and European Phase I/II clinical trials each involve a total of 12 patients, in groups of three (also called cohorts). The first group/cohort received a dosage of 50,000 cells, the second will receive 100,000 cells, the third will receive 150,000 cells and the final group/cohort will be dosed with 200,000 cells. The Most Recent Clinical Trial On April 15, 2013, ACT announced treatment of the first


myVisionTrack: An At-Home App for Monitoring Eye Disease Receives FDA Clearance

myVisionTrack™ is a hand-held, prescription-only medical device, provided as an app for the iPhone 4S, that has received clearance by the United States Food and Drug Administration (FDA) on March 24, 2013 to be marketed as an at-home method for monitoring the progression of degenerative eye diseases, such as macular degeneration and diabetic retinopathy. The myVisionTrack™ medical device is produced by Vital Art and Science (VAS),


Which Real-Life Factors Influence Adherence to Lucentis Treatment for Macular Degeneration?

A recent study, published in Graefe's Archive for Clinical and Experimental Ophthalmology, has attempted to "identify factors and problems influencing treatment adherence in patients undergoing anti-VEGF therapy for neovascular age-related macular degeneration under real-life conditions." Graefe's Archive is an international journal that presents original clinical reports and experimental studies by ophthalmologists and vision research scientists in order to provide rapid


Three Blind Mice and the National Institutes of Health Present the Documentary Film "Going Blind"

I was pleased to learn that the March 2013 National Institutes of Health Clinical Center Newsletter features the documentary film Going Blind: Coming out of the Dark about Vision Loss and its producer/director Joe Lovett. The National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, is the nation's largest hospital devoted entirely to


My Journey into Ophthalmology by Guest Blogger Irv Arons

Guest blogger Irv Arons is the creator of – and driving force behind – Irv Arons' Journal, an online compendium of the latest information on ophthalmics, medical lasers, and new drugs and devices for the treatment of age-related macular degeneration (AMD). Until his retirement in 2005, Irv was a consultant to the ophthalmic industry for over 30 years, and to the medical laser industry for over 20 years. I have been following Irv's informative blog for several years, and have great respect for his depth and breadth of knowledge regarding developments in stem cell therapy, gene therapy, and emerging


The Argus II Retinal Prosthesis ("Bionic Eye") Receives Humanitarian Use FDA Approval

On February 14, 2013, Second Sight Medical Products, Inc. received approval from the U.S. Food and Drug Administration (FDA) for the Argus II Retinal Prosthesis System, also called the "artificial retina" or "bionic eye." The mission of Sylmar, California-based Second Sight is to "develop, manufacture, and market implantable visual prosthetics to enable blind individuals to achieve greater independence." The Argus II has been approved to treat adults with severe to profound


Advancing Laboratory Treatments into Human Studies by Dr. Stephen Rose, Foundation Fighting Blindness

Stephen Rose, Ph.D., is the Chief Research Officer of the Foundation Fighting Blindness, Inc.. The urgent mission of the Foundation is to drive the research that will provide preventions, treatments, and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases. Dr. Rose's essay, entitled "Found in Translation: Taking on the Challenge of Advancing Treatments into Human Studies," appears in the Winter 2013 edition of


Gene Therapy and Leber Congenital Amaurosis: Update from the National Eye Institute

The following update addressing the role of gene therapy in the treatment of Leber congenital amaurosis (LCA), an inherited and progressive eye disease, is adapted, with permission, from a National Eye Institute news brief entitled New Findings Suggest Need for Combined Strategy in Treatment of Rare Form of Blindness. The mission of the National Eye Institute is to "conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases,


Positive Phase III Clinical Trial Results for Totally Blind Persons with Sleep Disorders

On January 23, 2013, Vanda Pharmaceuticals, Inc. announced positive Phase III clinical trial results from the recently completed Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon (RESET) study; in addition, on December 18, 2012, Vanda announced positive Phase III clinical trial results from the Safety and Efficacy of Tasimelteon (SET) study. Tasimelteon is an experimental drug treatment for totally blind individuals with no light perception who experience a sleep problem called "Non-24-Hour Sleep-Wake Disorder." In the United States, this disorder affects approximately 65,000 totally blind


A Promising New Method for Administering Glaucoma Medication

A promising (but not yet proven) treatment for glaucoma is the use of punctal plugs to deliver an accurate and consistent dosage of glaucoma medication. A major concern in glaucoma treatment is compliance with a medication regimen: ensuring that individuals use their eye drops every day and in the correct dosage. The consequences of poor compliance can lead to surgery, vision impairment, or even blindness. Small eye drop containers are not easy to


Have Researchers Identified an Early Predictor for Glaucoma?

A new study, published in the January 2013 issue of Ophthalmology, concludes that blood vessel changes within the eye could be an early warning sign of an increased risk for glaucoma. Ophthalmology, the official journal of the American Academy of Ophthalmology, publishes original, peer-reviewed reports of research in ophthalmology, including treatment methods, the latest drug findings, and results of clinical trials. The Study Authors


A Nationwide Study Is Investigating Genetic and Other Risk Factors for Macular Degeneration

Researchers at the Jules Stein Eye Institute of the University of California at Los Angeles are continuing to recruit participants for a nationwide study investigating the heredity and exposure risk factors that lead to the development of age-related macular degeneration. The GARM II Study The goal of the Genetics of Age-Related Maculopathy (GARM II) Study is:


New (Positive) Clinical Trial Results for Totally Blind Persons with Sleep Disorders

On December 18, 2012, Vanda Pharmaceuticals, Inc. announced positive Phase III clinical trial results from the recently completed Safety and Efficacy of Tasimelteon (SET) study. Tasimelton is an experimental drug treatment for totally blind individuals with no light perception who experience a sleep problem called "Non-24-Hour Sleep-Wake Disorder." In the United States, this disorder affects approximately 65,000 totally blind individuals who lack the light sensitivity necessary to reset their internal "body clocks."


The Latest Developments in Stem Cell Therapy for Macular Disease

Since November 2010, I have been following Advanced Cell Technology's (ACT) quest to implement successful clinical trials for macular eye disease, using human embryonic stem cells. ACT's U.S. and European Phase I/II clinical trials each involve a total of 12 patients, in groups of three (also called cohorts). The first group/cohort received a dosage of 50,000 cells, the second will receive 100,000 cells, the third will receive 150,000 cells and the final group/cohort will be dosed with 200,000 cells. ACT also has announced that Scotland's NHS Lothian


New Developments in Glaucoma Treatment: Micro-Stents

Year One results from the HYDRUS I clinical trial of the Hydrus Microstent, which has the potential for long-term reduction of intraocular [i.e., within the eye] pressure in patients with open-angle glaucoma, were presented at the 2012 American Academy of Ophthalmology Annual Meeting, held from November 10-13 in Chicago, Illinois. Ivantis, Inc., an Irvine, California-based company


A Phase 2 Clinical Trial for a New Glaucoma Treatment

Aerie Pharmaceuticals, Inc. has announced positive results for a Phase 2a clinical trial of experimental/investigational drug AR-13324 as a potential eye drop treatment for primary open-angle glaucoma. About Aerie Pharmaceuticals Aerie Pharmaceuticals, Inc., located in Bedminster, New Jersey and Research Triangle Park, North Carolina, is a privately held biotechnology


Phase II Clinical Trial to Begin: Squalamine Eye Drops for Wet Macular Degeneration

Ohr Pharmaceutical, Inc. has announced that it is commencing Phase II clinical trials to evaluate the safety and effectiveness of its Squalamine Eye Drops as a potential treatment for wet age-related macular degeneration (AMD). The Phase II study will enroll 120 participants at 21 clinical ophthalmology centers


Cataracts and Alzheimer's Disease: Are They Related?

Recently, I learned about a fascinating study in which researchers have proposed a possible (but not proven) genetic link between Alzheimer's disease and age-related cataracts. The Public Library of Science (PLoS) The study, entitled Delta-Catenin Is Genetically and Biologically Associated with Cortical Cataract and Future Alzheimer-Related Structural and Functional Brain Changes (I will explain/decode!), was published in the September 11, 2012 issue of


A Potential New Drug for Macular Degeneration, Now in Clinical Trials

Allergan, Inc. has entered Phase IIb clinical trials for experimental drug AGN-150998 as a potential treatment for wet age-related macular degeneration (AMD), specifically as an injectable medication designed to inhibit abnormal retinal blood vessel growth (i.e., an anti-VEGF treatment, explained below). Allergan, Inc. is a multi-specialty health care company focused on discovering, developing, and commercializing innovative pharmaceuticals, biologics, and medical


Updates On a Clinical Trial for Totally Blind Individuals with Sleep Disorders

Vanda Pharmaceuticals, Inc., a biotechnology company in Rockville, MD, is continuing to recruit study participants for a Phase III clinical trial of an experimental drug treatment for totally blind individuals with no light perception who experience a sleep problem called "Non-24-Hour Sleep-Wake Disorder." In the United States, this disorder affects approximately 65,000 totally blind individuals who lack the light sensitivity necessary to reset their internal "body clocks." About the Study


The FDA Approves Lucentis for Diabetic Macular Edema

Here is excellent news for individuals who have diabetes and associated diabetic macular edema: On August 10, 2012, the United States Food and Drug Administration (FDA) approved Genetech's Lucentis (generic name ranibizumab) for the treatment of diabetic macular edema (DME). In its approval announcement, the FDA noted that Lucentis is for use in persons with "good diabetic sugar control" and is designed to be given once a month as an injection into the eye by a qualified health care professional. About Diabetic Macular Edema


Using Microneedles To Deliver Drugs to the Retina: Helpful for Macular Degeneration?

Using a Microneedle for Drug Delivery to the Posterior Segment of the Eye was published in the July 2012 issue of Investigative Ophthalmology & Visual Science, the official journal of the Association for Research in Vision and Ophthalmology (ARVO). ARVO is an international organization that encourages and assists research, training, publication, and dissemination of knowledge in vision and ophthalmology, including low


Tracking the Latest Developments in Stem Cell Therapy for Macular Disease

Since November 2010, I have been following Advanced Cell Technology's (ACT) quest to implement successful clinical trials for macular eye disease, using human embryonic stem cells. Here is an update of ACT's progress to date: Moorfields Eye Hospital On July 27, 2012, ACT announced the treatment of the third patient in its European Phase I/II clinical trials for Stargardt's disease, using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. The most recent surgery was performed at Moorfields Eye Hospital in London,


Avastin and Lucentis for Macular Degeneration: Head-to-Head Once Again

Year Two results from the Comparison of Age-Related Macular Degeneration (AMD) Treatments Trials (CATT) that evaluated the effectiveness of Avastin (bevacizumab) versus Lucentis (ranibizumab) in a head-to-head clinical trial are now available. CATT is a multi-center, prospective clinical trial, funded by the National Eye Institute (NEI), a component agency


Avastin and Lucentis: Cardiovascular Risks? A New Canadian Study Says No

Last week, I read yet another intriguing research study regarding the age-related macular degeneration (AMD) drugs Lucentis and Avastin. The newly-released Canadian study investigated the risk of cardiovascular events [i.e., heart attack, congestive heart failure, blood clotting, and stroke] in patients who were receiving either Avastin or Lucentis injections for retinal disease. I've blogged about research results involving both drug treatments on a number of occasions, including


The FDA Approves a New Stent Device for Glaucoma Surgery with Cataracts

On June 25, 2012, the U.S. Food and Drug Administration (FDA) announced that it had approved the iStent Trabecular Micro-Bypass Stent System. This is the first stent device approved for use in combination with cataract surgery to reduce intraocular [i.e., within the eye] pressure in adult patients with mild or moderate open-angle glaucoma and a


Another Potential "Eye Drop" Treatment for (Dry) Macular Degeneration

MacuCLEAR, Inc. has announced that it is commencing Phase III clinical trials for MC-1101, its topical [i.e., eye drop] drug for the treatment of early-stage dry age-related macular degeneration (AMD), based on positive feedback during the company's end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA). Recently, I also reported on another eye drop treatment in


A New Stem Cell Clinical Trial for Dry Age-Related Macular Degeneration

Last week, StemCells, Inc. announced the initiation of a Phase I/II clinical trial of its human neural stem cell product for the treatment of dry macular degeneration, to be conducted at the Retina Foundation of the Southwest's (RFSW) Anderson Vision Research Center in Dallas, Texas. A summary of StemCell Inc.'s


The Joslin Diabetes Center's Incredible "50-Year Medalists"

Researchers at the The Joslin Diabetes Center and the Juvenile Diabetes Research Foundation (JDRF) have completed a study of 158 people who have lived with documented type 1 diabetes for 50 years or more, and who comprise a portion of the Joslin 50-Year Medalists cohort. The researchers concluded that a significant percentage of this unique group of patients


A Potential "Eye Drop" Treatment for (Wet) Macular Degeneration

Ohr Pharmaceutical, Inc., a company that is dedicated to the clinical development of new drugs for underserved therapeutic needs, has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA) for its Squalamine Eye Drops as a potential treatment for wet


Could One Cause of Macular Degeneration Be a Viral Infection?

Recently, I read a fascinating study in which the researchers have proposed a possible new approach (one of many) to the treatment of age-related macular degeneration, or AMD. The study, entitled Macrophage Activation Associated with Chronic Murine Cytomegalovirus Infection Results in More Severe Experimental Choroidal Neovascularization (I will explain/decode!),


A New Website from the National Institutes of Health: Clinical Research Trials and You

From a press release from the National Institutes of Health (NIH): The National Institutes of Health has created a new website, NIH Clinical Research Trials and You, to help people learn more about clinical trials, why they matter, and how to participate. From the first cure of a solid tumor with chemotherapy to the use of nitroglycerin in response to heart attacks, clinical research trials – or research studies involving people – have played a vital role in improving health and quality of life for people around the


Updates on the Progress of Clinical Trials for a Retinal Implant for Retinitis Pigmentosa

How It Began On November 3, 2010, a report entitled Subretinal electronic chips allow blind patients to read letters and combine them to words was published online in the Proceedings of the Royal Society B: Biological Sciences. Proceedings B is the Royal Society's biological research journal, dedicated to the rapid publication of high-quality research papers. The paper summarized a 15-year research project to develop and test a functional retinal implant for patients with retinitis pigmentosa (RP). The project was headed by Eberhart


FDA Approves EYLEA™ for the Treatment of Wet Macular Degeneration

Anatomy of the EYLEA™ Drug Approval Process In February 2011, Regeneron Pharmaceuticals, Inc. announced that the company had submitted a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for Regeneron's VEGF Trap-Eye (now called EYLEA™), a potential injectable drug treatment for wet age-related macular degeneration (AMD). The FDA next announced


The Chronic Care for Age-Related Macular Degeneration Study and Quality of Life

As our readers know, I always like to look outside the United States for professional inspiration. This week, I read about a most interesting study/trial that is being conducted in Switzerland. The Chronic Care for Age-Related Macular Degeneration Study (CHARMED) is an ongoing clinical trial that employs the Chronic Care Model as its primary


A New Clinical Trial for Patients Who Do not Respond to Lucentis or Avastin for Macular Degeneration

This week, I learned about a new clinical trial for a drug that shows promise in the treatment of wet macular degeneration (AMD) in patients who have not responded to treatment with either Avastin or Lucentis, the two drug interventions most commonly used at present. The drug is called iSONEP™ and it has been created by Lpath, a San Diego, California-based pharmaceutical


An Updated Clinical Trial for Totally Blind Individuals with Sleep Disorders

Vanda Pharmaceuticals, Inc., a biotechnology company in Rockville, MD, is currently recruiting study participants for a Phase 3 clinical trial of an experimental drug treatment for totally blind individuals with no light perception who experience a sleep problem called "Non-24-Hour Sleep-Wake Disorder." In the United States, this disorder affects approximately 65,000


More Frequent Visual Field Testing May Lead To Earlier Detection of Glaucoma Progression

Here's more good news about glaucoma that builds upon, and enhances, quality of life issues. I was interested to read Influence of Visual Field Testing Frequency on Detection of Glaucoma Progression with Trend Analyses, an exploration of whether an increased frequency of visual field testing leads to earlier detection of glaucoma progression, in the August 8,


Could Avastin and Lucentis Trigger Elevated Eye Pressure?

The August 2011 issue of the British Journal of Ophthalmology contains an article that caught my attention. In the article, entitled Sustained elevation of intraocular pressure after intravitreal injections of anti-VEGF agents (Translation: Sustained high pressure within the eye after injection with Avastin or Lucentis), the authors investigated several critical issues surrounding the longer-term safety of Lucentis and Avastin, injectable drugs used to treat macular degeneration. Some Background


Update on the Triggerfish® "Smart" Contact Lens for Glaucoma

Several months ago, I highlighted the Triggerfish® "smart" contact lens and a prototype implantable microchip, two devices that demonstrate exceptional promise in measuring and monitoring intraocular (i.e., within the eye) pressure that characterizes the most common types of glaucoma. Thus, I was pleased to learn that two new


An Excellent Series on Macular Degeneration from The New York Times

As our readers know, I am committed to investigating and reporting the latest information about macular degeneration, including ongoing research and clinical trial results; thus I am extremely pleased to note that the New York Times is presenting a three-pronged series on macular diseases and disorders. In the latest installment of the New York Times Patient Voices series, health writer Tara Parker-Pope introduces


Update on Stem Cell Clinical Trials for Dry Macular Degeneration and Stargardt's Disease

On Tuesday, July 12, 2011, Advanced Cell Technology (ACT) announced the treatment of the first two patients in its two Phase I/II clinical trials for Stargardt's disease and dry macular degeneration (AMD), using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. The procedures were carried out by principal investigator Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of


Stem Cells for Stargardt's Disease

Wow. This is surprising – and groundbreaking – news. First, here's some background: In August of this year, The Wall Street Journal reported that Judge Royce Lamberth of U.S. District Court in Washington, D.C. had issued a preliminary injunction against federal funding for human embryonic stem cell research. The judge stated that federal funding violated a 1996 law prohibiting federal money for research in which a human embryo was destroyed. Many federally funded stem cell research projects were placed on "clinical hold"


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