Clinical trial NCT00088283: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinal Vein Occlusion
Keywords: CRVO
Central Retinal Vein Occlusion
RVO
Retinal Vein Occlusion
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2004-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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