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| Sponsors and Collaborators: |
Eyetech Pharmaceuticals Pfizer |
|---|---|
| Information provided by: | Eyetech Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00088283 |
Purpose
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.
The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a “pretend” injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).
This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a “pretend” injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinal Vein Occlusion |
Drug: pegaptanib sodium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO |
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2004 |
This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 35 Study Locations More Information
| Study ID Numbers: | EOP 1011B |
| Study First Received: | July 23, 2004 |
| Last Updated: | January 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00088283 |
| Health Authority: | United States: Food and Drug Administration |
|
CRVO Central Retinal Vein Occlusion RVO Retinal Vein Occlusion |
|
Eye Diseases Vascular Diseases Retinal Degeneration Edema Macular Degeneration Blindness Thrombosis Macular Edema |
Embolism and Thrombosis Embolism Retinal Vein Occlusion Neoplasm Metastasis Venous Thrombosis Retinal Diseases Retinal degeneration |
|
Cardiovascular Diseases |
