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| Sponsors and Collaborators: |
Regeneron Pharmaceuticals Bayer |
| Information provided by: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00509795 |
Purpose
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.
| Condition | Intervention | Phase |
|
Neovascular Age-Related Macular Degeneration |
Biological: VEGF Trap-Eye Drug: Comparator |
Phase III |
| Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
| MedlinePlus related topics: | Macular Degeneration |
| Drug Information available for: | Aflibercept |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration |
| Estimated Enrollment: | 1200 |
| Study Start Date: | August 2007 |
| Arms | Assigned Interventions |
| 1: Experimental | Biological: VEGF Trap-Eye |
| 2: Experimental | Biological: VEGF Trap-Eye |
| 3: Experimental | Biological: VEGF Trap-Eye |
| 4: Active Comparator | Drug: Comparator |
Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Prior treatment with anti-VEGF agents as follows:
Contacts and Locations| Contact: Regeneron | 866-549-8439 | VIEW1study@rtp.ppdi.com |
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Show 180 Study Locations |
| Regeneron Pharmaceuticals |
| Bayer |
| Study Director: | Avner Ingerman, MD | Regeneron Pharmaceuticals |
More Information
| Study ID Numbers: | VGFT-OD-0605 |
| First Received: | July 31, 2007 |
| Last Updated: | June 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00509795 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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