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
Data Collection
Cardiovascular Diseases+8
+ Eye Diseases
+ Macular Degeneration
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 35 locations
Retina Associates, SW
Tucson, United StatesJules Stein Institute
Los Angeles, United StatesOrange County Retina Associates
Santa Ana, United States