A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
Condition: Wet Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Faricimab; Aflibercept; Sham Procedure
Intervention description: Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.; Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).; The sham is a procedure that mimics an intravitreal 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: 671.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; nAMD; neovascular age-related macular degeneration; choroidal neovascularization secondary to age-related macular degeneration

Summary:

      This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab
      administered at intervals as specified in the protocol, compared with aflibercept once every
      8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular
             degeneration (nAMD) in the study eye

          -  Ability to comply with the study protocol, in the investigator's judgment

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use acceptable contraceptive measures that result in
             failure rate <1% per year during the treatment period and for at least 3 months after
             the final dose of study treatment

          -  Other protocol-specified inclusion criteria may apply

        Exclusion Criteria:

          -  Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of
             mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on
             Day 1

          -  Pregnancy or breastfeeding, or intention to become pregnant during the study

          -  CNV due to causes other than AMD in the study eye

          -  Any history of macular pathology unrelated to AMD affecting vision or contributing to
             the presence of intraretinal or subretinal fluid in the study eye

          -  Any concurrent intraocular condition in the study eye that, in the opinion of the
             investigator, could either reduce the potential for visual improvement or require
             medical or surgical intervention during the study

          -  Uncontrolled glaucoma in the study eye

          -  Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in
             the study eye

          -  Prior IVT administration of faricimab in either eye

          -  History of idiopathic or autoimmune-associated uveitis in either eye

          -  Active ocular inflammation or suspected or active ocular or periocular infection in
             either eye

          -  Other protocol-specified exclusion criteria may apply