Discovery Eye Foundation
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Clinical Trials for Dry AMD

Clinical trials are the final research phase before a treatment is approved for the general public. Once a drug or treatment has been developed, it is tested in humans through a succession of clinical trials.

Research on treatments starts in the laboratory where scientists work to identify the processes involved. These are called Pre-Clinical studies. Clinical trials begin with Phase I trials, which test the treatment on a small number of people for safety and best dose. Phase II involves several hundred subjects to test for effectiveness. Phase III expands the study to thousands of people in order to confirm effectiveness and monitor safety and side effects. After the drug or treatment has been approved by the Food and Drug Administration (FDA) and made available for public use, studies continue to track side effects and success.

These clinical trials are recruiting patients to volunteer.  Participants in any clinical trial are chosen based on eligibility.  If you are interested in participating, ask your retinal specialist if you would be a good candidate.  Or, use the information in each section to contact the coordinator of the trial.  Some of these clinical trials have many sites throughout the U.S.  Others are in one location in the U.S. or in other countries.  You will always need to be examined before you are accepted and you must be available for appointments.

Clinical trials listed below are divided into three time frames. The first are the Clinical Trials that are still "Recruiting" patients to participate in the study. The second are the Trials that are currently in progress, but are "Not Recruiting" new patients. The last and final stage are those studies that are "Completed" already and have some results to report.



Pills for Dry AMD-Acucela-Recruiting Print E-mail
The Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride is underway to study an oral medication for geographic atrophy (GA) in dry AMD.  Currently known as ACU-4429, the pill is being tested in several different dosages, to determine its safety and tolerability. 
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Eye Drops for Dry AMD - not recruiting Print E-mail

Share Share Alcon Research is completing a study of an eye drop to treat geographic atrophy, an advanced form of dry macular degeneration.

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Sirolimus-Not Recruiting Print E-mail
Sirolimus helps prevent inflammation and may help treat geographic atrophy(GA), the advanced form of dry macular degeneration.  In this study, the drug is injected into the eye every three months.
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Copaxone (glatiramer acetate) - Not Recruiting Print E-mail
Share Share This small trial of 30 people with dry AMD involves a weekly vaccination with the drug Copaxone.  This is NOT an injection in the eye.
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Othera Eye Drops – Not Recruiting Print E-mail
This is a Phase II clinical trial of an eye drop, using 198 patients with geographic atrophy (GA). GA is the advanced form of dry macular degeneration in which an entire area of cell death occurs. Geographic atrophy is the greatest risk factor for advancing from dry AMD to wet AMD.
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Complement C5aR Inhibition – not recruiting Print E-mail

C5aR is a complement factor that has been found localized in drusen and on the edges of geographic atrophy.  Preclinical studies have suggested that blocking C5aR could be useful in stopping wet macular degeneration. One of the hopes we have in research is that we can find something that will stop dry AMD from advancing to wet AMD. For dry AMD, this drug is being studied to see if it will reduce drusen and the size of geographic atrophy.

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Fenretinide Pill – Terminated Print E-mail

Share Share In a Phase II clinical trial of the pill fenretinide,  for patients with dry macular degeneration and geographic atrophy(GA) has been completed with positive results.  The data showed that fenretinide slowed the growth of geographic atrophy lesions by 45% in the 300 mg dose. Followup at the 24 month point maintained this result.

Unfortunately, because of a change in manufacturing processes in the middle of this trial, the data cannot be accepted for review by the FDA.  Unless some investor is willing to fund a repeat of the clinical trial, this promising treatment will probably never come to market.

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Rheopheresis - Unproven Print E-mail
Rheopheresis
Rheopheresis is still an unproven therapy for dry macular degeneration. The clinical trial was completed and further development was abandoned for financial reasons.  The FDA has not approved this therapy, though it is available in Germany.
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Laser for Drusen - Trial Completed Print E-mail
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT). This multi-site trial, coordinated by the University of Pennsylvania used low-intensity laser to treat drusen in people with dry AMD. The study has been completed but participants are still being followed.
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