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Posts tagged age-related macular degeneration

ARVO 2018: Port Delivery System Designed to Reduce Burden of Lucentis Injections for Wet AMD

Dr. Christopher Brittain, Genentech medical director, discusses his company’s port delivery system, a tiny capsule implanted into the eye, for delivery of Lucentis® over a period of a few months. The device is currently in a Phase 2 clinical trial.

The image on the right shows the port implanted into an eye.

ARVO 2018: Studies Show Mediterranean Diet May Lower Advanced AMD Risk

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Several research studies have suggested that the Mediterranean diet (MeDi) – which is rich in fruits, vegetables, legumes, cereals, and fish – may be good for your health, including lowering your risk of an early visit from the grim reaper.

Known as the EYE-RISK CONSORTIUM, a large international research collaboration found that the MeDi reduced the risk of advanced age-related macular degeneration (AMD) by 39 percent. The researcher’s findings were highlighted in a poster on May 1 at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Honolulu.
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Retinal Patch Performs Promisingly in Clinical Trial for Dry AMD Patients

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Regenerative Patch Technologies, a company developing stem-cell-derived treatments for people with retinal diseases, has reported encouraging results for the first five patients with advanced, dry age-related macular degeneration (AMD) participating in a Phase 1/2a clinical trial for its therapy – a patch comprised of a layer of retinal pigment epithelial (RPE) cells on a synthetic scaffold. The treatment is known as the California Project to Cure Blindness–Retinal Pigment Epithelium 1 (CPCB-RPE1).
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Vision Improvements Reported in Early Stem Cell Trial for Wet AMD

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Two patients with advanced wet age-related macular degeneration (AMD) in a Phase I clinical trial demonstrated improved visual acuity sustained for one year after a sheet of retinal pigment epithelial (RPE) cells derived from embryonic stem cells was transplanted under their retinas. Each patient had one eye treated. Vision improvement for one patient was 29 letters or about 6 lines on an eye chart. The other had a gain of 21 letters or about 4 lines.
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Ophthotech Launching Human Study of Emerging Therapy for Stargardt Disease

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Ophthotech, a biopharmaceutical company developing therapies for eye diseases, has enrolled the first patient in its Phase 2b clinical trial of Zimura® for people with Stargardt disease caused by mutations in the gene ABCA4. The 120-participant study will be taking place at more than 30 sites. Data and knowledge gleaned from ProgStar, a natural history study for people with Stargardt disease funded by the Foundation Fighting Blindness, was used in the design of the clinical trial.
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Unregulated Stem-Cell Therapy Causes Severe Vision Loss for Three Florida Women

A report today in The New England Journal of Medicine (NEJM) describes the cases of three women with age-related macular degeneration (AMD) who lost much of their eyesight after receiving ocular injections of stem cells derived from their own fat tissue. All of the women had good enough eyesight to drive before the procedures. Each paid $5,000 to receive the injections from a private clinic in Sunrise, Florida. The New York Times and other major media outlets have published news stories on the NEJM report.
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FFB-CRI Leads Effort to Identify Outcome Measures for Therapies in Clinical Trials

Side view of a retina as captured by SD-OCT. The EZ Width is the yellow line extending between the arrows. The patient has advanced RP with significant loss of peripheral vision.

A key to gaining regulatory approval for an emerging retinal-disease therapy is quickly and accurately demonstrating that it saves or restores vision in a clinical trial. Though the goal sounds simple enough, proving that a potential treatment is working is actually difficult. That’s because commonly used measures of visual function — including visual acuity and visual fields — are not always reliable for evaluating vision changes in many people with inherited retinal conditions.

For example, visual acuity can remain stable for someone with retinitis pigmentosa (RP) for decades. While visual fields for people with RP contract over time, measuring the changes objectively is challenging; results for a given patient can vary significantly, even for the same patient on the same day.
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Nobel-Prize-Winning Stem-Cell Researcher Delivers Keynote at FFB-Funded Conference in Kyoto

Shinya Yamanaka, M.D., Ph.D.It was only 10 years ago that Shinya Yamanaka, M.D., Ph.D., discovered how to convert a person’s skin cells into stem cells by tweaking just four genes. The historical breakthrough landed Dr. Yamanaka the 2012 Nobel Prize in Physiology-Medicine, because it meant that patients could be their own stem-cell donors. Known as induced pluripotent stem cells (iPSC), they are now being used to develop powerful therapies and drug-screening tools including those for the retina.

To the delight of nearly 300 retinal researchers from around the world attending the FFB-funded RD2016 meeting, September 19-24 in Kyoto, Japan, Dr. Yamanka discussed his early clinical trial for iPSC-derived retinal pigment epithelial (RPE) cells for a 78-year-old woman with advanced wet age-related macular degeneration (AMD). The study met its main goal – safety – and he and his collaborator, Masayo Takahashi, M.D., Ph.D., are planning to treat additional patients in the near future.

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Pixium Vision Reports Progress in Development of Two Advanced Bionic Retina Systems

Man wearing Pixium Bionic Retina GlassesWhile several companies and laboratories around the world are at various stages of bionic-retina development, Pixium Vision  located in France, is progressing impressively down two paths for these high-tech, vision-restoring systems. Both approaches show strong, near-term potential for providing meaningful vision to people who are otherwise blind from retinal diseases such as retinitis pigmentosa and age-related macular degeneration (AMD).

Pixium recently announced that its IRIS®II bionic vision system received a CE Mark, the regulatory approval necessary for marketing medical devices and other products in Europe. The IRIS II is further down the company’s clinical development pipeline than its more technologically advanced PRIMA system, which was originally conceptualized by researchers at Stanford University, and is expected to enter a clinical trial later this year for AMD.

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Back in Baltimore – VISIONS 2016, FFB’s National Conference, Returns to Its Founding City

Baltimore's Inner HarborFor the second year in a row, the Foundation Fighting Blindness’ national conference — this year titled VISIONS 2016 — will take place in FFB’s founding city of Baltimore, Maryland, June 30-July 3. More than 500 people are expected to attend the event, which will offer dozens of research- and lifestyle-focused sessions designed for people who are visually impaired and sighted as well.
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