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

Sponsor

Eyetech Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00088283

Collaborator

Pfizer (Industry)

Enrollment

Locations

2.6

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion	Drug: pegaptanib sodium	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Centers, P.C., Northwest Location	Tucson	Arizona	United States	85704
2	Retina Associates, SW	Tucson	Arizona	United States	85710
3	Jules Stein Institute	Los Angeles	California	United States	90095
4	Orange County Retina Associates	Santa Ana	California	United States	92705
5	New England Retina Associates	Hamden	Connecticut	United States	06518
6	Retina Group of Florida	Fort Lauderdale	Florida	United States	33334
7	Bascom Palmer Eye Institute	Miami	Florida	United States	33136
8	The University of Chicago	Chicago	Illinois	United States	60637
9	Macula-Retina-Vitreous Service	Indianapolis	Indiana	United States	46280
10	Vitreo-Retinal Consultants & Surgeons, P.A.	Wichita	Kansas	United States	67214
11	Retina Associates	New Orleans	Louisiana	United States	70155
12	Retina Group of Washington	Chevy Chase	Maryland	United States	20815
13	Cumberland Valley Retina Center	Hagerstown	Maryland	United States	21740
14	New England Eye Center	Boston	Massachusetts	United States	02111
15	Massachusetts Eye & Ear Infirmary	Boston	Massachusetts	United States	02114
16	Lahey Clinic, The Eye Institute	Peabody	Massachusetts	United States	01960
17	Kresge Eye Institute	Detroit	Michigan	United States	48201
18	Associated Retinal Consultants	Royal Oak	Michigan	United States	48073
19	Eye Foundation of Kansas City	Kansas City	Missouri	United States	64108
20	Charlotte Eye, Ear, Nose and Throat Associates, P.A.	Charlotte	North Carolina	United States	28210
21	Duke University Eye Center	Durham	North Carolina	United States	27710
22	The Cleveland Clinic	Cleveland	Ohio	United States	44195
23	Retina Associates of Cleveland Inc.	Lakewood	Ohio	United States	44107
24	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma	United States	73104
25	Casey Eye Institute	Portland	Oregon	United States	97239
26	Wills Eye Institute Retina Research	Philadelphia	Pennsylvania	United States	19107
27	Palmetto Retina Center	Columbia	South Carolina	United States	29204
28	Southeastern Retina Associates	Knoxville	Tennessee	United States	37909
29	Retina Research Institute of Texas, LLC	Abilene	Texas	United States	79606
30	Austin Retina Associates	Austin	Texas	United States	78705
31	Texas Retina Associates	Dallas	Texas	United States	75231
32	VitreoRetinal Consultants	Houston	Texas	United States	77030
33	Valley Retina Associates, P.A.	McAllen	Texas	United States	78503
34	University of Wisconsin	Madison	Wisconsin	United States	53705
35	The Eye Institute	Milwaukee	Wisconsin	United States	53226