search
Back to results

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

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegaptanib sodium
Sponsored by
Eyetech Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring CRVO, Central Retinal Vein Occlusion, RVO, Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Centers, P.C., Northwest Location
  • Retina Associates, SW
  • Jules Stein Institute
  • Orange County Retina Associates
  • New England Retina Associates
  • Retina Group of Florida
  • Bascom Palmer Eye Institute
  • The University of Chicago
  • Macula-Retina-Vitreous Service
  • Vitreo-Retinal Consultants & Surgeons, P.A.
  • Retina Associates
  • Retina Group of Washington
  • Cumberland Valley Retina Center
  • New England Eye Center
  • Massachusetts Eye & Ear Infirmary
  • Lahey Clinic, The Eye Institute
  • Kresge Eye Institute
  • Associated Retinal Consultants
  • Eye Foundation of Kansas City
  • Charlotte Eye, Ear, Nose and Throat Associates, P.A.
  • Duke University Eye Center
  • The Cleveland Clinic
  • Retina Associates of Cleveland Inc.
  • Dean A. McGee Eye Institute
  • Casey Eye Institute
  • Wills Eye Institute Retina Research
  • Palmetto Retina Center
  • Southeastern Retina Associates
  • Retina Research Institute of Texas, LLC
  • Austin Retina Associates
  • Texas Retina Associates
  • VitreoRetinal Consultants
  • Valley Retina Associates, P.A.
  • University of Wisconsin
  • The Eye Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 23, 2004
Last Updated
January 17, 2007
Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00088283
Brief Title
Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
CRVO, Central Retinal Vein Occlusion, RVO, Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Retina Centers, P.C., Northwest Location
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Associates, SW
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Jules Stein Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Orange County Retina Associates
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Macula-Retina-Vitreous Service
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Vitreo-Retinal Consultants & Surgeons, P.A.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Retina Associates
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70155
Country
United States
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Cumberland Valley Retina Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
New England Eye Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts Eye & Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Lahey Clinic, The Eye Institute
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Associated Retinal Consultants
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Eye Foundation of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Associates of Cleveland Inc.
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Wills Eye Institute Retina Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Southeastern Retina Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Retina Research Institute of Texas, LLC
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
VitreoRetinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Associates, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
The Eye Institute
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19365011
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs