At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 373 enrolled
Drug / intervention
Ranibizumabdrug
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.
A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Ranibizumab for Diabetic Macular Edema. Completed, enrolled 373 participants across 68 sites in 13 countries.
Detailed Summary
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesBelgium, Czechia, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartSep 2010
Primary CompletionApr 2013
TodayJul 2026
First PostedJul 29, 2010
Enrollment StartSep 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.9 years ago
Interventions
Ranibizumabdrug
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.