Conditions: Wet Age Related Macular Degeneration
Keywords: wet AMD macular degeneration ranibizumab mono-bilateral poor visual acuity retinal disease eye disease Angiogenesis Inhibitors Angiogenesis Modulating Agents
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 1049
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).

Detailed description:

Arms:
arm 1: Administered as an Intravitreal injection

Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).

Protocol document: