Conditions: Age Related Macular Degeneration
Keywords: Age-related macular degeneration, ranibizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 353
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Ranibizumab 0.3 mg - 3 times monthly, then quarterly intervention 2: Ranibizumab 0.5 mg - 3 times monthly, then quarterly intervention 3: Ranibizumab 0.3 mg monthly
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document: