Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.

Phase 1

Completed

• Conditions: Choroidal Neovascularization
• Interventions: Drug: ranibizumab

• Registration Number: NCT00395551
• Lead Sponsor: Ophthalmic Consultants of Boston

Brief Summary

The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-11-01
• Study First Submitted QC: 2006-11-02
• Study First Posted: 2006-11-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-07
• Last Update Posted: 2010-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• active choroidal neovascularization

Exclusion Criteria

• pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ranibizumab	ranibizumab	ranibizumab 0.5mg intravitreal injection

Primary Outcome Measures

Name	Time	Method
The primary outcome measures for safety and tolerability	Mean change in visual acuity from baseline to 6 months & 12 months

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures for efficacy	Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA