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

Completed · Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT02699450

Run by

Hoffmann-La Roche

People needed

229

Starts

2016-04-27

Expected to finish

2017-12-14

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Macular edema associated with diabetic retinopathy
• Decreased visual acuity attributable primarily to DME
• Diagnosis of diabetes mellitus

You may not qualify if…

• 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

Where it is running

• Associated Retina Consultants — Phoenix, Arizona, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
• Retina Associates Southwest PC — Tucson, Arizona, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• United Med Res Inst — Inglewood, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Ophthalmic Clinical Trials San Diego — Oceanside, California, United States
• Southern CA Desert Retina Cons — Palm Desert, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Retina Consultants of Southern — Colorado Springs, Colorado, United States
• Rand Eye — Deerfield Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Univ of Illinois at Chicago — Chicago, Illinois, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Illinois Retina Associates SC — Oak Park, Illinois, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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