Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)
|ClinicalTrials.gov Identifier: NCT01198327|
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion||Drug: ranibizumab Other: Peripheral Laser||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
- Incidence of Serious Adverse Events. [ Time Frame: 24 mos ]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 ]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 ]Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|