Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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, lucentis
Other: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|