A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

Overview

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).

Full Title of Study: “A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2021

Interventions

  • Drug: Faricimab
    • Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
  • Drug: Aflibercept
    • 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).
  • Drug: Sham Procedure
    • 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.

Arms, Groups and Cohorts

  • Experimental: Faricimab
  • Active Comparator: Aflibercept

Clinical Trial Outcome Measures

Primary Measures

  • Average Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 48
    • Time Frame: From Baseline up to 48 weeks
    • BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters

Secondary Measures

  • Change from Baseline in BCVA Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Gaining ≥0 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants on Different Treatment Intervals at Weeks 48, 60, and 112
    • Time Frame: Weeks 48, 60, and 112
  • Number of Study Drug Injections Received Through Weeks 48, 60, and 112
    • Time Frame: Weeks 48, 60, and 112
  • Average Change from Baseline in Central Subfield Thickness (CST) at Week 48
    • Time Frame: From Baseline up to 48 weeks
  • Change from Baseline in CST Over Time
    • Time Frame: From Baseline up to 112 weeks
  • Percentage of Participants with Absence of Intraretinal Fluid Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants with Absence of Subretinal Fluid Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants with Absence of Intraretinal Cysts Over Time
    • Time Frame: Up to 112 weeks
  • Percentage of Participants with Absence of Pigment Epithelial Detachment Over Time
    • Time Frame: Up to 112 weeks
  • Change from Baseline in Total Area of Choroidal Neovascularization (CNV) Lesion at Weeks 48 and 112
    • Time Frame: Baseline, Weeks 48 and 112
  • Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112
    • Time Frame: Baseline, Weeks 48 and 112
  • Percentage of Participants with Ocular Adverse Events
    • Time Frame: Up to 116 weeks
  • Percentage of Participants with Non-Ocular Adverse Events
    • Time Frame: Up to 116 weeks
  • Plasma Concentration of Faricimab Over Time
    • Time Frame: Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112
  • Percentage of Participants with Presence of Anti-Drug Antibodies
    • Time Frame: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche
  • Overall Contact(s)
    • Reference Study ID Number: GR40306 www.roche.com/about_roche/roche_worldwide.htm, 888-662-6782 (U.S. Only), global-roche-genentech-trials@gene.com

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