CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 671 enrolled
Drug / intervention
Ranibizumabdrug
Likely dose
Ranibizumab 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01780935
NCT01780935Phase 3Completed

A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

Novartis Pharmaceuticals·interventional·Posted Jan 31, 2013·Updated Aug 14, 2017

In Brief

A Phase 3 clinical trial evaluating Ranibizumab for Neovascular Age-related Macular Degeneration. Completed, enrolled 671 participants across 92 sites in 24 countries.

Detailed Summary

This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections. The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Canada, Colombia, Czechia, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Italy, Lithuania, Mexico, Netherlands, Panama, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2013
Enrollment StartJun 3, 2013
Primary CompletionJul 9, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.4 years ago

Interventions

Ranibizumabdrug

Intravitreal injections of 0.5 mg Ranibizumab