What is the FDA's role in glaucoma related clinical trials?
A: The FDA's 2100 scientists review test results submitted by the developers of all medications and medical devices to determine whether clinical trials are warranted. Additionally, the administration approves the action plan (known as the protocol) and the team of researchers selected to conduct the research. Final approval by the FDA, post-trials, determines whether the product can be made available to the public.
Where can I get more information about clinical trials?
A: If you or someone you know is interested in learning more,
1) Communicate with your doctor. Because small groups and select doctors are involved with trials, don't expect your doctor to have specific details on each study. But asking questions about your glaucoma and your involvement with a study should be top on your list.
2) Be sure you understand that expressing trial interest does not guarantee involvement nor does it guarantee that you will be included in the treatment group.
3) Try these resources: the FDA (1-888-INFO-FDA or 301-827-4570), the National Eye Institute (301-496-5248), Pharmaceutical Research and Manufacturers of America (202-835-3400), and CenterWatch (617-856-5900).
Q: I would like to know how the Memantine study is progressing for use in glaucoma. What is dosage of Memantine which they are working on? Can you also tell me which institution is involved in the tests.
A: Results for this trial will likely not be available until 2007 at least. The sponsor is Allergan, Inc.(Irvine, CA) and they can be contacted for further information.
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