At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Diabetes mellitus (Type 1 or 2)
- ✓Retinal thickening (macular edema) secondary to diabetes involving the center of the fovea with central macular thickness ≥275 µm on OCT
- ✓Best corrected visual acuity in the study eye of 20/40 to 20/320 (ETDRS)
- ✕Panretinal photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
- ✕Previous anti-angiogenic drug treatment (pegaptanib, anecortave acetate, bevacizumab, ranibizumab, etc) in either eye within 3 months before Day 0
- ✕Proliferative diabetic retinopathy in the study eye (except inactive, regressed PDR)
- ✕Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Ranibizumab and Sham injection for Diabetes Mellitus and Macular Edema. Completed, enrolled 382 participants.
Detailed Summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473330 (Protocol ID FVF4170g). The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.
Study Details
Timeline
Interventions
Sterile solution for intravitreal injection.