Overview

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

Status:
Recruiting
Trial end date:
2023-10-17
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
Chugai Pharmaceutical
Treatments:
Aflibercept
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