Conditions: Age-related Macular Degeneration
Keywords: Lucentis AMD Age-related macular degeneration Subfoveal neovascular age-related macular degeneration Wet AMD Macular degeneration Ranibizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1097
Healthy volunteers: no

Brief summary:
This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study.

Detailed description:

Arms:
arm 1: Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. arm 2: Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months. arm 3: Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally. arm 4: Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.

Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Sterile solution for intravitreal injection.

Protocol document: