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Clinical Trials

What are clinical trials?

A: Clinical trials are research studies conducted with people to find better ways to diagnose, prevent and treat disease. These studies are done on human patients to evaluate whether the new treatment, procedure or device is safe and effective.

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.

What steps are involved in FDA approval?

A: Before the new medication or device is approved for public use, it must be tested in a three-phase process by investigators who must follow strict scientific and ethical principles. After successfully completing these phases, the developer is required to file a "New Drug Application" (NDA) or a "Pre-Market Application" (510K) with the FDA. The submitted report (which discloses the results of all studies and manufacturing details) is analyzed by an appointed committee to determine whether final FDA approval will be given.

What happens in a clinical trial?

A: Patients are assigned at random to either a control or treatment group in order to avoid bias and assure more objective results. People in the treatment group receive the new drug or are treated with the new device; the control group participants receive a more standard treatment, no treatment or a placebo (a look alike that has no active drug).

What percentages of tested drugs or devices actually receive final approval for public use?

A: Approximately 20%.

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).

Memantine Study

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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