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

Retinal Vein Occlusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088283
• Other study ID #: EOP 1011B
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2004
• Last updated: January 17, 2007
• Start date: May 2004

Study information

• Verified date: January 2007
• Source: Eyetech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• pegaptanib sodium

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas, LLC	Abilene	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Massachusetts Eye & Ear Infirmary	Boston	Massachusetts
United States	New England Eye Center	Boston	Massachusetts
United States	Charlotte Eye, Ear, Nose and Throat Associates, P.A.	Charlotte	North Carolina
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	The University of Chicago	Chicago	Illinois
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Palmetto Retina Center	Columbia	South Carolina
United States	Texas Retina Associates	Dallas	Texas
United States	Kresge Eye Institute	Detroit	Michigan
United States	Duke University Eye Center	Durham	North Carolina
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Cumberland Valley Retina Center	Hagerstown	Maryland
United States	New England Retina Associates	Hamden	Connecticut
United States	VitreoRetinal Consultants	Houston	Texas
United States	Macula-Retina-Vitreous Service	Indianapolis	Indiana
United States	Eye Foundation of Kansas City	Kansas City	Missouri
United States	Southeastern Retina Associates	Knoxville	Tennessee
United States	Retina Associates of Cleveland Inc.	Lakewood	Ohio
United States	Jules Stein Institute	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Valley Retina Associates, P.A.	McAllen	Texas
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	The Eye Institute	Milwaukee	Wisconsin
United States	Retina Associates	New Orleans	Louisiana
United States	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma
United States	Lahey Clinic, The Eye Institute	Peabody	Massachusetts
United States	Wills Eye Institute Retina Research	Philadelphia	Pennsylvania
United States	Casey Eye Institute	Portland	Oregon
United States	Associated Retinal Consultants	Royal Oak	Michigan
United States	Orange County Retina Associates	Santa Ana	California
United States	Retina Associates, SW	Tucson	Arizona
United States	Retina Centers, P.C., Northwest Location	Tucson	Arizona
United States	Vitreo-Retinal Consultants & Surgeons, P.A.	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Eyetech Pharmaceuticals	Pfizer

Country where clinical trial is conducted

United States, 

External Links

•   Sponsor's Website