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

Completed · Phase 3 · Has a placebo group

Conditions studied: Wet Macular Degeneration

In brief

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).

Key facts

Study ID

NCT03823287

Run by

Hoffmann-La Roche

People needed

671

Starts

2019-02-19

Expected to finish

2022-01-18

Last updated by the study team

2025-07-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Retina Consultants of Southern California — Redlands, California, United States
• University of California, Davis, Eye Center — Sacramento, California, United States
• Retina Consultants of Southern — Colorado Springs, Colorado, United States
• Retina Group of New England — New London, Connecticut, United States
• Rand Eye — Deerfield Beach, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Northwestern Medical Group/Northwestern University — Chicago, Illinois, United States
• Retina Associates — Lenexa, Kansas, United States
• Johns Hopkins Med — Baltimore, Maryland, United States
• Retina Group of Washington — Chevy Chase, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Associated Retinal Consultants — Grand Rapids, Michigan, United States
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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