NCT01948830

Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

A 12-month, Phase 3b, Randomized, Visual Acuity Assessor-masked, Multicenter Study Assessing the Efficacy and Safety of Ranibizumab 0.5mg in Treat and Extend Regimen Compared to Monthly Regimen, in Patients With Neovascular Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Age-related Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.5mg	0.5 mg ranibizumab (intravitreal injections) prefilled syringe)
DRUG	Ranibizumab 0.5mg	0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Timeline

• Start date: 2013-12-17
• Primary completion: 2015-11-19
• Completion: 2015-11-19
• First posted: 2013-09-24
• Last updated: 2017-04-17
• Results posted: 2016-12-15

Locations

91 sites across 19 countries: Belgium, Chile, Croatia, Denmark, Egypt, Germany, Hungary, India, Israel, Italy, Portugal, Russia, Slovakia, Slovenia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom