Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
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|ClinicalTrials.gov Identifier: NCT00088283|
Recruitment Status : Completed
First Posted : July 26, 2004
Last Update Posted : January 19, 2007
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 or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion||Drug: pegaptanib sodium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088283
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