CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 135 enrolled
Drug / intervention
ranibizumab 0.5 mgdrug
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/NCT02366468
NCT02366468Phase 4Completed
CompareCT.gov

A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema

Novartis Pharmaceuticals·interventional·Posted Feb 19, 2015·Updated Jan 4, 2019

In Brief

A Phase 4 clinical trial evaluating ranibizumab 0.5 mg for Diabetic Retinopathy. Completed, enrolled 135 participants across 30 sites.

Detailed Summary

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartFeb 23, 2015
Primary CompletionJun 8, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.4 years ago

Interventions

ranibizumab 0.5 mgdrug

intravitreal injection