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NCT00088283 · ClinicalTrials.gov registry record · Phase 2
Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
A Phase 2 study of Retinal Vein Occlusion, sponsored by Eyetech Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT00088283 is a Phase 2 study of Retinal Vein Occlusion that has completed, run by Eyetech Pharmaceuticals. The registered enrollment target is 90 participants, below the 851-participant average among 11 other Retinal Vein Occlusion trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT00088283, a Phase 2 study of Retinal Vein Occlusion, has completed, sponsored by Eyetech Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG pegaptanib sodium
Study Locations (20)
Massachusetts
- New England Eye Center - Boston
- Massachusetts Eye & Ear Infirmary - Boston
- Lahey Clinic, The Eye Institute - Peabody
Arizona
- Retina Centers, P.C., Northwest Location - Tucson
- Retina Associates, SW - Tucson
California
- Jules Stein Institute - Los Angeles
- Orange County Retina Associates - Santa Ana
Florida
- Retina Group of Florida - Fort Lauderdale
- Bascom Palmer Eye Institute - Miami
Maryland
- Retina Group of Washington - Chevy Chase
- Cumberland Valley Retina Center - Hagerstown
Michigan
- Kresge Eye Institute - Detroit
- Associated Retinal Consultants - Royal Oak
Connecticut
- New England Retina Associates - Hamden
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2004-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088283
The ClinicalTrials.gov registry entry for NCT00088283 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 851-participant average among 11 other Retinal Vein Occlusion trials with a reported enrollment target (89% lower). The listed sponsor is Eyetech Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Retinal Vein Occlusion appearing as the primary indexed condition, and to 1 intervention - of which pegaptanib sodium is the first listed.
NCT00088283 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT00088283 about?
NCT00088283 is a clinical study titled "Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)". 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...
What is the current status of trial NCT00088283?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2004-05.
What conditions does trial NCT00088283 study?
This clinical trial studies the following conditions: Retinal Vein Occlusion.
What interventions are being tested in trial NCT00088283?
The interventions under investigation include: pegaptanib sodium (DRUG).
Who is sponsoring clinical trial NCT00088283?
This trial is sponsored by Eyetech Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088283 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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