NCT00403039

Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

Phase I Study of Intravitreally Administered Ranibizumab in 20 Subjects With Macular Edema Associated With CRVO.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Vitreous -Retina- Macula Consultants of New York · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema

Detailed description

This is an open-label, Phase I study of intravitreally administered ranibizumab in 20 subjects with macular edema associated with CRVO. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 ± 2 days for a total of 3 injections. Thereafter they are to be evaluated every month until month 12. If the patients have signs of increased intraretinal hemorrhage or a persistence / increase in central macular edema as determined by optical coherence tomography when compared to their last visit, are eligible for re-injection at that monthly visit.

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Ranibizumab (Lucentis )

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2006-11-23
• Last updated: 2016-01-01

Locations

1 site across 1 country: United States