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

NCT04740905

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Macular Edema, Branch Retinal Vein Occlusion

Interventions: Faricimab, Aflibercept, Sham Procedure

Countries: United States, Argentina, Australia, Austria, Brazil, China, Czechia, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (150)

Phoenix, Arizona, United States
Tucson, Arizona, United States
Campbell, California, United States
Encino, California, United States
Pasadena, California, United States
Poway, California, United States
Colorado Springs, Colorado, United States
Waterford, Connecticut, United States
Melbourne, Florida, United States
Plantation, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Marietta, Georgia, United States
‘Aiea, Hawaii, United States
Oak Forest, Illinois, United States
Springfield, Illinois, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Royal Oak, Michigan, United States
Edina, Minnesota, United States
Chesterfield, Missouri, United States
Reno, Nevada, United States
Teaneck, New Jersey, United States
Hauppauge, New York, United States
Liverpool, New York, United States
Hickory, North Carolina, United States
Cincinnati, Ohio, United States
Rapid City, South Dakota, United States
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