A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema

• Status: Completed
• Trial end date: 2017-12-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Macular edema associated with diabetic retinopathy

• Decreased visual acuity attributable primarily to DME

• Diagnosis of diabetes mellitus

Exclusion Criteria:

• 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