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

Condition(s) targeted: Retinal Vein Occlusion

Intervention: pegaptanib sodium (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eyetech Pharmaceuticals

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Retina Centers, P.C., Northwest Location, Tucson, Arizona 85704, United States

Retina Associates, SW, Tucson, Arizona 85710, United States

Jules Stein Institute, Los Angeles, California 90095, United States

Orange County Retina Associates, Santa Ana, California 92705, United States

New England Retina Associates, Hamden, Connecticut 06518, United States

Retina Group of Florida, Fort Lauderdale, Florida 33334, United States

Bascom Palmer Eye Institute, Miami, Florida 33136, United States

The University of Chicago, Chicago, Illinois 60637, United States

Macula-Retina-Vitreous Service, Indianapolis, Indiana 46280, United States

Vitreo-Retinal Consultants & Surgeons, P.A., Wichita, Kansas 67214, United States

Retina Associates, New Orleans, Louisiana 70155, United States

Cumberland Valley Retina Center, Hagerstown, Maryland 21740, United States

Retina Group of Washington, Chevy Chase, Maryland 20815, United States

Massachusetts Eye & Ear Infirmary, Boston, Massachusetts 02114, United States

New England Eye Center, Boston, Massachusetts 02111, United States

Lahey Clinic, The Eye Institute, Peabody, Massachusetts 01960, United States

Associated Retinal Consultants, Royal Oak, Michigan 48073, United States

Kresge Eye Institute, Detroit, Michigan 48201, United States

Eye Foundation of Kansas City, Kansas City, Missouri 64108, United States

Charlotte Eye, Ear, Nose and Throat Associates, P.A., Charlotte, North Carolina 28210, United States

Duke University Eye Center, Durham, North Carolina 27710, United States

The Cleveland Clinic, Cleveland, Ohio 44195, United States

Retina Associates of Cleveland Inc., Lakewood, Ohio 44107, United States

Dean A. McGee Eye Institute, Oklahoma City, Oklahoma 73104, United States

Casey Eye Institute, Portland, Oregon 97239, United States

Wills Eye Institute Retina Research, Philadelphia, Pennsylvania 19107, United States

Palmetto Retina Center, Columbia, South Carolina 29204, United States

Southeastern Retina Associates, Knoxville, Tennessee 37909, United States

VitreoRetinal Consultants, Houston, Texas 77030, United States

Texas Retina Associates, Dallas, Texas 75231, United States

Valley Retina Associates, P.A., McAllen, Texas 78503, United States

Retina Research Institute of Texas, LLC, Abilene, Texas 79606, United States

Austin Retina Associates, Austin, Texas 78705, United States

The Eye Institute, Milwaukee, Wisconsin 53226, United States

University of Wisconsin, Madison, Wisconsin 53705, United States

Sponsor's Website

Starting date: May 2004
Last updated: January 17, 2007