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

Completed · Phase 3 · Has a placebo group

Conditions studied: Macular Edema, Central Retinal Vein Occlusion, Hemiretinal 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 patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

Key facts

Study ID

NCT04740931

Run by

Hoffmann-La Roche

People needed

729

Starts

2021-03-02

Expected to finish

2023-07-12

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 central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), 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)
• 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 sheathotomy
• 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

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Retina Associates Southwest PC — Tucson, Arizona, United States
• Retinal Diagnostic Center — Campbell, California, United States
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• East Bay Retina Consultants — Oakland, California, United States
• California Eye Specialists Medical group Inc. — Pasadena, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• West Coast Retina Medical Group — San Francisco, California, United States
• Retina Consultants of Southern Colorado PC — Colorado Springs, Colorado, United States
• Colorado Retina Associates, PC — Lakewood, Colorado, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Advanced Research — Deerfield Beach, Florida, United States
• Rand Eye — Deerfield Beach, Florida, 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
• 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
• Northwestern Medical Group/Northwestern University — Chicago, Illinois, United States
• Retina Associated Ltd — Elmhurst, Illinois, United States
• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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