NCT00275821

Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

A Randomized, Double-masked, Active-controlled, Multi-center Study Comparing the Efficacy and Safety of Ranibizumab Administered as Two Dosing Regimens in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.3 mg - 3 times monthly, then quarterly	Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
DRUG	Ranibizumab 0.5 mg - 3 times monthly, then quarterly	Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
DRUG	Ranibizumab 0.3 mg monthly	Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-01-12
• Last updated: 2011-03-16
• Results posted: 2011-03-16

Locations

1 site across 1 country: Switzerland