Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)
This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.
Retinal Vein Occlusion
Other: Peripheral Laser
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extended Follow-up of Patients With Macular Edema Due to bRanch rETinal Vein Occlusion (BRVO) or centrAl Retinal veIn occlusioN (CRVO) Previously Treated With Intravitreal Ranibizumab|
- Incidence of Serious Adverse Events. [ Time Frame: 24 mos ] [ Designated as safety issue: Yes ]Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
- Mean Changes in Visual Acuity [ Time Frame: 24 mos from study baseline ] [ Designated as safety issue: No ]Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.
- Mean Change in Retinal Thickness [ Time Frame: 24 mos from study baseline ] [ Designated as safety issue: No ]Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
|Study Start Date:||August 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Ranibizumab as needed
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
Other Name: RBZ, lucentisOther: Peripheral Laser
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Other Name: Laser
There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198327
|United States, California|
|Retina-Vitreous Associates Medical Group|
|Beverly Hills, California, United States, 90211|
|Retinal Consultants Medical Group|
|Sacremento, California, United States, 95819|
|United States, Georgia|
|Augusta,, Georgia, United States, 30909|
|United States, Massachusetts|
|Ophthalmic consultants of Boston|
|Boston, Massachusetts, United States, 02114-2587|
|United States, New Jersey|
|Retina Associates of New Jersey|
|Teaneck, New Jersey, United States, 07666|
|United States, Texas|
|Retina Consultants of Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Peter A Campochiaro, MD||Johns Hopkins University|