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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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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:
- CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
- Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.
Exclusion Criteria:
- Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
- Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
- Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
Contacts and Locations
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Additional Information:
No publications provided by Eyetech Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00088283 History of Changes |
| Other Study ID Numbers: | EOP 1011B |
| Study First Received: | July 23, 2004 |
| Last Updated: | January 17, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eyetech Pharmaceuticals:
|
CRVO Central Retinal Vein Occlusion RVO Retinal Vein Occlusion |
Additional relevant MeSH terms:
|
Macular Edema Retinal Vein Occlusion Blindness Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013