Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

NCT ID: NCT00088283

Last Updated: 2007-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pegaptanib sodium

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Eyetech Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Retina Centers, P.C., Northwest Location

Tucson, Arizona, United States

Site Status

Retina Associates, SW

Tucson, Arizona, United States

Site Status

Jules Stein Institute

Los Angeles, California, United States

Site Status

Orange County Retina Associates

Santa Ana, California, United States

Site Status

New England Retina Associates

Hamden, Connecticut, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

The University of Chicago

Chicago, Illinois, United States

Site Status

Macula-Retina-Vitreous Service

Indianapolis, Indiana, United States

Site Status

Vitreo-Retinal Consultants & Surgeons, P.A.

Wichita, Kansas, United States

Site Status

Retina Associates

New Orleans, Louisiana, United States

Site Status

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina Center

Hagerstown, Maryland, United States

Site Status

New England Eye Center

Boston, Massachusetts, United States

Site Status

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, United States

Site Status

Lahey Clinic, The Eye Institute

Peabody, Massachusetts, United States

Site Status

Kresge Eye Institute

Detroit, Michigan, United States

Site Status

Associated Retinal Consultants

Royal Oak, Michigan, United States

Site Status

Eye Foundation of Kansas City

Kansas City, Missouri, United States

Site Status

Charlotte Eye, Ear, Nose and Throat Associates, P.A.

Charlotte, North Carolina, United States

Site Status

Duke University Eye Center

Durham, North Carolina, United States

Site Status

The Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Retina Associates of Cleveland Inc.

Lakewood, Ohio, United States

Site Status

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Casey Eye Institute

Portland, Oregon, United States

Site Status

Wills Eye Institute Retina Research

Philadelphia, Pennsylvania, United States

Site Status

Palmetto Retina Center

Columbia, South Carolina, United States

Site Status

Southeastern Retina Associates

Knoxville, Tennessee, United States

Site Status

Retina Research Institute of Texas, LLC

Abilene, Texas, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

VitreoRetinal Consultants

Houston, Texas, United States

Site Status

Valley Retina Associates, P.A.

McAllen, Texas, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

The Eye Institute

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Wroblewski JJ, Wells JA 3rd, Adamis AP, Buggage RR, Cunningham ET Jr, Goldbaum M, Guyer DR, Katz B, Altaweel MM; Pegaptanib in Central Retinal Vein Occlusion Study Group. Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Arch Ophthalmol. 2009 Apr;127(4):374-80. doi: 10.1001/archophthalmol.2009.14.

Reference Type DERIVED
PMID: 19365011 (View on PubMed)

Related Links

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http://www.eyetech.com

Sponsor's Website

Other Identifiers

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EOP 1011B

Identifier Type: -

Identifier Source: org_study_id

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