At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
Ranibizumab 0.5 mg +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.
Multicenter Randomized Open-label Three-arms Controlled 12 Months Clinical Proof of Concept Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy
In Brief
A Phase 2 clinical trial evaluating Ranibizumab 0.5 mg and Panretinal laser photocoagulation for Proliferative Diabetic Retinopathy (PDR). Completed, enrolled 107 participants across 23 sites.
Detailed Summary
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProliferative Diabetic Retinopathy (PDR)
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartDec 2012
Primary CompletionNov 2016
Study CompletionDec 2017
TodayJul 2026
First PostedMay 9, 2012
Enrollment StartDec 11, 2012
Primary CompletionNov 30, 2016
Study CompletionDec 5, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.1 years ago
Interventions
Ranibizumab 0.5 mgdrug
Pre-filled syringe for intravitreal injection
Panretinal laser photocoagulationprocedure
PRP treatment following DRS guidelines