ranibizumab
DrugIntravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
Other names: RBZ, lucentis
NCT Number: NCT01198327
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
Other names: RBZ, lucentis
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Other names: Laser
Time frame: 24 mos
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
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.
Time frame: 24 mos from study baseline
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
Peter A Campochiaro, MD
Other
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
Acronym: RETAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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