A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Condition: Macular Edema; Central Retinal Vein Occlusion; Hemiretinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Faricimab; Aflibercept; Sham Procedure
Intervention description: Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.; Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).; The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Intervention MeSH terms: Aflibercept; Faricimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 729.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRVO; HRVO

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 patients with macular
      edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 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 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