CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,049 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/NCT01986907
NCT01986907Phase 4Completed
CompareCT.gov

A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye

Novartis Pharmaceuticals·interventional·Posted Nov 19, 2013·Updated Jul 19, 2019

In Brief

A Phase 4 clinical trial evaluating ranibizumab for Wet Age Related Macular Degeneration. Completed, enrolled 1,049 participants across 101 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWet Age Related Macular Degeneration
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 19, 2013
Enrollment StartMar 4, 2014
Primary CompletionJun 15, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.6 years ago

Interventions

ranibizumabdrug

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).