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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 testing 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.
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Alcon Research is recruiting 550 patients for a study of an eye drop to treat geographic atrophy, an advanced form of dry macular degeneration. |
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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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The Implantable Miniature Telescope (IMT) is being tested in the United Kingdom for use in AMD.
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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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The Implantable Miniature Telescope (IMT) is being tested for use in AMD. No patients are being recruited because the data has already been submitted to the FDA. On March 28, 2009, the FDA Advisory Committee for Medical Devices recommended that the IMT be approved, with conditions. The FDA usually follows the advice of the Committee, but is not required to do so. The conditions include post-approval surveillance and reporting.
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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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Another complement factor under investigation is C5aR, which has been found localized in drusen and on the edges of geographic atrophy. Preclinical studies have suggested that blocking C5aR could be useful
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This is a Phase II study involving 51 patients with dry AMD. Ciliary Neurotrophic Factor (CNTF) is a protein that effects cellular function and is classified as a “neuroprotective” agent. That means that it stops cell death and may rescue the photoreceptors, even if they are already on their way to dying. CNTF has been shown to retard or reverse retinal degeneration in the animal model. Researchers hope it will slow disease progression in dry AMD.
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This is a Phase II clinical trial of a PILL for patients with dry macular degeneration and geographic atrophy(GA). Two hundred forty-five patients are part of this two year study. The one year interim data was announced in April 2009. The data showed that fenretinide slowed the growth of geographic atrophy lesions by 45% in the 300 mg dose. Followup is expected to be completed by Spring 2010.
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Rheopheresis Rheopheresis is still an unproven therapy for dry macular degeneration. The clinical trial was completed and further development was abandoned for financial reasons.
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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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