CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 377 enrolled
Drug / intervention
Ranibizumab +1 moredrug
Likely dose
Not stated in 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/NCT00473330
NCT00473330Phase 3Completed
CompareCT.gov

A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus

Genentech, Inc.·interventional·Posted May 15, 2007·Updated Apr 17, 2017

In Brief

A Phase 3 clinical trial evaluating Ranibizumab and Sham injection for Diabetes Mellitus and Macular Edema. Completed, enrolled 377 participants.

Detailed Summary

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473382 (Protocol ID FVF4168g). The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Macular Edema
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2007
Enrollment StartJun 1, 2007
Primary CompletionNov 1, 2010
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.1 years ago

Interventions

Ranibizumabdrug

Sterile solution for intravitreal injection.

Sham injectiondrug