A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

Completed · Phase 3 · Has a placebo group

Conditions studied: Macular Edema, Branch Retinal Vein Occlusion

In brief

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

Key facts

Study ID

NCT04740905

Run by

Hoffmann-La Roche

People needed

553

Starts

2021-03-02

Expected to finish

2023-06-12

Last updated by the study team

2024-08-06

Who can join

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

You may qualify if…

• Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
• Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

You may not qualify if…

• Any major illness or major surgical procedure within 1 month before screening
• Uncontrolled blood pressure
• Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Ocular Exclusion Criteria for Study Eye:
• History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
• Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
• Macular laser (focal/grid) in the study eye at any time prior to Day 1
• Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
• Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
• Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
• Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
• Ocular Exclusion Criteria for Both Eyes:
• Prior IVT administration of faricimab in either eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

Where it is running

• Retina Associates Southwest PC — Tucson, Arizona, United States
• Retinal Diagnostic Center — Campbell, California, United States
• The Retina Partners — Encino, California, United States
• California Eye Specialists Medical group Inc. — Pasadena, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• Retina Consultants of Southern Colorado PC — Colorado Springs, Colorado, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• Retina Associates of Florida, LLC — Tampa, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Prairie Retina Center — Springfield, Illinois, United States
• Cumberland Valley Retina PC — Hagerstown, Maryland, United States
• Tufts Medical Center; Ophthalmology — Boston, Massachusetts, United States
• Assoc Retinal Consultants PC — Royal Oak, Michigan, United States
• VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota — Edina, Minnesota, United States
• Midwest Vision Research Foundation — Chesterfield, Missouri, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Retina Associates of NJ — Teaneck, New Jersey, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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