Conditions: Age-related Macular Degeneration Choroidal Neovascularization
Keywords: Ranibizumab, Lucentis, choroidal neovascularization, age-related macular degeneration, treat and extend regimen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 650
Healthy volunteers: no

Brief summary:
This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

Detailed description:
This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.

There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.

Arms:
arm 1: Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11 arm 2: Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11

Interventions: intervention 1: Ranibizumab 0.5mg intervention 2: Ranibizumab 0.5mg
Intervention descriptions: intervention 1: 0.5 mg ranibizumab (intravitreal injections) prefilled syringe) intervention 2: 0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Protocol document: