Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Chugai Pharmaceutical
Conditions:
Macular Edema
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 intra...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
729 Patients enrolled
Trial Details
Trial ID
NCT04740931
Start Date
March 2 2021
End Date
July 12 2023
Last Update
August 6 2024
Active Locations (194)
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1
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States, 85206
2
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85014
3
Retina Associates Southwest PC
Tucson, Arizona, United States, 85704
4
Retinal Diagnostic Center
Campbell, California, United States, 95008