NCT00395707

Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The National Retina Institute · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.

Detailed description

This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	Lucentis	0.3mg/0.05 ml or 0.5mg/0.05 ml
DRUG	Ranibizumab	0.3mg/0.05 ml or 0.5mg/0.05 ml
DRUG	Ranibizumab (Lucentis)	0.3mg/0.05 ml intravitreally
DRUG	Ranibizumab (Lucentis)	0.5mg/0.05 ml

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-11-03
• Last updated: 2009-02-09

Locations

2 sites across 1 country: United States