A Study of RO6867461 in Participants With Center-involving Diabetic Macular Edema (BOULEVARD)
- Diabetic Macular Edema
- United States
NCT02699450 RG7716 BP30099
Clinical Trial Results
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.
A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 36-Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema
- Macular edema associated with diabetic retinopathy
- Decreased visual acuity attributable primarily to DME
- Diagnosis of diabetes mellitus
- High risk proliferative diabetic retinopathy
- Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
- Uncontrolled glaucoma
- Current or history of ocular disease in the study eye other than DME
- Major illness or major surgical procedure within 1 month prior to Day 1
- Uncontrolled blood pressure
- Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening
- Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1
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