At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 384 enrolled
Drug / intervention
Ranibizumab (RFB002) +3 moredrug
Likely dose
Ranibizumab (RFB002) 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.
A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients
In Brief
A Phase 3 clinical trial evaluating Ranibizumab (RFB002), Laser, and 2 other interventions for Diabetic Macular Edema and Visual Impairment. Completed, enrolled 384 participants across 28 sites.
Detailed Summary
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema, Visual Impairment
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartNov 2014
Primary CompletionJan 2017
TodayJul 2026
First PostedOct 8, 2014
Enrollment StartNov 5, 2014
Primary CompletionJan 17, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.7 years ago
Interventions
Ranibizumab (RFB002)drug
Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
Laserprocedure
Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
Sham injectiondrug
Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
Sham laserprocedure
Imitation of an active laser