CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 241 enrolled
Drug / intervention
ranibizumab +1 moredrug
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/NCT01135914
NCT01135914Phase 3Completed
CompareCT.gov

A Canadian 12-month, Prospective, Randomized, Open-label, Multicenter, Laser-controlled Phase IIIb Study Assessing the Efficacy, Safety and Cost-efficacy of Ranibizumab as Combination and Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema.

Novartis Pharmaceuticals·interventional·Posted Jun 3, 2010·Updated Oct 23, 2014

In Brief

A Phase 3 clinical trial evaluating ranibizumab and Laser for Diabetic Macular Edema. Completed, enrolled 241 participants across 20 sites.

Detailed Summary

To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2010
Enrollment StartJul 1, 2010
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.1 years ago

Interventions

ranibizumabdrug

Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.

Laserprocedure

Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.