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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224626

Enrollment

640

Registered

2019-04-03

Start date

2019-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

investigational material(s) Generic name etc : RO6867461 INN of investigational material : Faricimab Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Treatment-naive CNV secondary to AMD (nAMD) - 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

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

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Average Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 48 BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart	—

Secondary

Measure	Time frame
safety efficacy - Change from Baseline in BCVA Over Time - Percentage of Participants Gaining >=15, >=10, >=5, or >=0 Letters in BCVA from Baseline Over Time - Percentage of Participants Avoiding Loss of >=15, >=10, >=5, or >0 in BCVA from Baseline Over Time - Change from Baseline in CST Over Time - Change from Baseline in Total Area of CNV Lesion at Weeks 48 and 112 - Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112 - Percentage of Participants with Ocular Adverse Events - Percentage of Participants with Non-Ocular Adverse Events - Plasma Concentration of Faricimab Over Time	—

Measure

Time frame

safety efficacy - Change from Baseline in BCVA Over Time - Percentage of Participants Gaining >=15, >=10, >=5, or >=0 Letters in BCVA from Baseline Over Time - Percentage of Participants Avoiding Loss of >=15, >=10, >=5, or >0 in BCVA from Baseline Over Time - Change from Baseline in CST Over Time - Change from Baseline in Total Area of CNV Lesion at Weeks 48 and 112 - Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112 - Percentage of Participants with Ocular Adverse Events - Percentage of Participants with Non-Ocular Adverse Events - Plasma Concentration of Faricimab Over Time

—

Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026