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Sponsored by: |
Regeneron Pharmaceuticals |
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Information provided by: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00383370 |
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Condition | Intervention | Phase |
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Neovascular Age Related Macular Degeneration |
Drug: VEGF Trap |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study |
Estimated Enrollment: | 12 |
Study Start Date: | October 2006 |
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
No prior treatment with the following in the study eye:
United States, Florida | |
Fort Myers, Florida, United States | |
United States, New York | |
Lynbrook, New York, United States | |
United States, South Carolina | |
Columbia, South Carolina, United States | |
United States, Texas | |
Austin, Texas, United States |
Study Director: | Avner Ingerman, MD |
Study ID Numbers: | VGFT-OD-0603 |
Study First Received: | October 2, 2006 |
Last Updated: | July 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00383370 |
Health Authority: | United States: Food and Drug Administration |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |