NCT01198327

Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Peter A Campochiaro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	ranibizumab	Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
OTHER	Peripheral Laser	Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-09-10
• Last updated: 2014-01-13
• Results posted: 2014-01-13

Locations

6 sites across 1 country: United States