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

COMPLETEDPHASE3

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)

NCT03823287•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (161)

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, United States

Retina Associates Southwest PC

Tucson, Arizona, United States

Retinal Diagnostic Center

Campbell, California, United States

The Retina Partners

Encino, California, United States

Jacobs Retina center at the Shiley eye Institute UCSD

La Jolla, California, United States

South Coast Retina Center

Long Beach, California, United States

Southern CA Desert Retina Cons

Palm Desert, California, United States

California Eye Specialists Medical group Inc.

Pasadena, California, United States

Retina Consultants, San Diego

Poway, California, United States

Key Dates

Start Date

February 19, 2019

Primary Completion Date

October 26, 2020

Completion Date

January 18, 2022

Last Updated

July 23, 2025

Enrollment

671

ACTUAL participants

Conditions

Wet Macular Degeneration

Interventions

Faricimab

DRUG

Aflibercept

DRUG

Sham Procedure

PROCEDURE

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Age-related Wet Macular Degeneration

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ENROLLING_BY_INVITATIONPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration

Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)

Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration

EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection