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

January 17, 2007 updated by: Eyetech Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Centers, P.C., Northwest Location
      • Tucson, Arizona, United States, 85710
        • Retina Associates, SW
    • California
      • Los Angeles, California, United States, 90095
        • Jules Stein Institute
      • Santa Ana, California, United States, 92705
        • Orange County Retina Associates
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • New England Retina Associates
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Retina Group of Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Macula-Retina-Vitreous Service
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Vitreo-Retinal Consultants & Surgeons, P.A.
    • Louisiana
      • New Orleans, Louisiana, United States, 70155
        • Retina Associates
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye & Ear Infirmary
      • Boston, Massachusetts, United States, 02111
        • New England Eye Center
      • Peabody, Massachusetts, United States, 01960
        • Lahey Clinic, The Eye Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Eye Foundation of Kansas City
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye, Ear, Nose and Throat Associates, P.A.
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
      • Lakewood, Ohio, United States, 44107
        • Retina Associates of Cleveland Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Casey Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute Retina Research
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Palmetto Retina Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Southeastern Retina Associates
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas, LLC
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Vitreoretinal Consultants
      • McAllen, Texas, United States, 78503
        • Valley Retina Associates, P.A.
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • The Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

July 23, 2004

First Submitted That Met QC Criteria

July 23, 2004

First Posted (Estimate)

July 26, 2004

Study Record Updates

Last Update Posted (Estimate)

January 19, 2007

Last Update Submitted That Met QC Criteria

January 17, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOP 1011B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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