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.
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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REDD14NP– Quark
This Phase I study is recruiting patients with wet macular degeneration to receive a single injection of a drug designed to interfere with a gene that seems to be active in creating AMD.
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Sirolimus (Rapamycin)
MacuSight is currently recruiting patients with wet AMD for a Phase 2 study of an ocular sirolimus formulation in combination with Lucentis®. This is a randomized, multi-center study and is taking place throughout the United States. Sirolimus is designed to stop the growth of blood vessels in the macula.
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ATG003 Eye Drops
This study is investigating the use of an eye drop in patients who are already getting Lucentis or Avastin.
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CABERNET – Strontium-90 Beta Radiation Implant Trial
What this trial is about: CABERNET is a multicenter, randomized, controlled Phase III study that will enroll 450 subjects at 45 clinical centers worldwide. In this research, patients will receive either the standard injection of Lucentis® (ranibizumab) or the radiation plus Lucentis®.
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Enrollment is underway for a clinical trial for the treatment of wet age-related macular degeneration (AMD). The trial is sponsored by Theragenics Corporation® and will investigate the safety and ability of using the TheraSightTM Ocular Brachytherapy System to treat wet AMD.
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COBALT – Bevasiranib & Lucentis Combination Therapy
A Phase III clinical trial is no longer recruiting patients to participate in a comparison study between Lucentis and Bevasiranib. Opko Health, Inc.
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Regeneron Pharmaceuticals is recruiting for a Phase III clinical trial that will assess the safety and tolerability of their experimental drug for wet macular degeneration. This one year study will involve 1200 patients in the U.S. and Canada.
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This Phase I study (called ASap) will provide safety and tolerability information on the complement inhibitor (POT-4) injected into the eyes of patients with wet AMD. Earlier animal studies showed no toxicity even when injected at high concentrations. Participants received a single injection of the drug, with some patients receiving higher doses than others. This is a one year study, but information from the early data is being released.
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Here are some of the clinical trials that have been completed recently:
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