Clinical Trials for Macular Degeneration
It can take many years for a potential treatment for macular degeneration to work its way from the laboratory to rigorous testing and finally, approval by the Food and Drug Administration (FDA). The process begins in the lab with basic investigations using cells and specially bred animal models. Next, translational research moves the therapy to the human setting. Finally, the drug is tested on humans in clinical trials divided into three phases, I, II and III. These trials are used to determine the safety and effectiveness of the drug on progressively larger numbers of people. Normally, if the results are positive in the first two phases, the therapy will proceed to Phase III. The data gathering, analysis and reporting that are necessary to complete these trials can take several years. Those with macular degeneration or even healthy individuals may want to consider participating in clinical trials. Each trial has its own protocol or set of guidelines, and volunteers must meet certain criteria to qualify for inclusion. Before making a decision, get as much information as possible about the trials, and think seriously about the benefits and risks of volunteering. Those who participate will have access to potential new treatments, as well as medical care, and they may help others with macular degeneration. However, there may be side effects to the medications being tested or they may not be effective, and participation requires a certain time commitment.
The following websites contain information on clinical trials:
Centerwatch (www.centerwatch.com) provides information on government-sponsored human trials and recruitment, with locations, purpose, eligibility requirements and phone contacts.
ClinicalTrials.gov (www.clinicaltrials.gov) provides information about clinical research, including listings of active industry and government-sponsored clinical trials, research on new drug therapies and drugs recently approved by the Food and Drug Administration.
Last Reviewed On: 09/26/08