Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Regeneron Pharmaceuticals |
---|---|
Information provided by: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00320814 |
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Edema |
Drug: VEGF Trap-Eye |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema |
Enrollment: | 5 |
Study Start Date: | April 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
VEGF Trap-Eye: Experimental
single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
|
Drug: VEGF Trap-Eye
single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
|
This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Baltimore, Maryland, United States, 21287 | |
United States, North Carolina | |
Charlotte, North Carolina, United States, 28210 |
Study Director: | Avner Ingerman, MD | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals, Inc. ( Avner Ingerman, MD/Medical Monitor ) |
Study ID Numbers: | VGFT-OD-0512 |
Study First Received: | April 28, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00320814 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases Retinal degeneration |