At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 150 enrolled
Drug / intervention
Ranibizumab 0.3 mg intravitreal injection +1 moredrug
Likely dose
Ranibizumab 0.3 mg intravitreal injectionfrom 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 Phase I/II, Open Label, Multicenter, Randomized, Controlled Study of the Safety, Tolerability and Efficacy of Intravitreal Injections of 0.3 mg Ranibizumab Given Monthly Compared to a TReat and EXtend Protocol in Patients With Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating Ranibizumab 0.3 mg intravitreal injection and Guided Laser Photocoagulation for Diabetic Macular Edema. Completed, enrolled 150 participants across 3 sites.
Detailed Summary
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartNov 2013
Primary CompletionApr 2017
Study CompletionApr 2018
TodayJul 2026
First PostedSep 4, 2013
Enrollment StartNov 1, 2013
Primary CompletionApr 1, 2017
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.8 years ago
Interventions
Ranibizumab 0.3 mg intravitreal injectiondrug
Guided Laser Photocoagulationdevice