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

NCT03823287

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Wet Macular Degeneration

Interventions: Faricimab, Aflibercept, Sham Procedure

Countries: United States, Canada, Germany, Hungary, Israel, Italy, Japan, Mexico

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 overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (161)

Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Campbell, California, United States
Encino, California, United States
La Jolla, California, United States
Long Beach, California, United States
Palm Desert, California, United States
Pasadena, California, United States
Poway, California, United States
Redlands, California, United States
Sacramento, California, United States
Colorado Springs, Colorado, United States
New London, Connecticut, United States
Deerfield Beach, Florida, United States
Melbourne, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Lenexa, Kansas, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Chesterfield, Missouri, United States
Florissant, Missouri, United States
Reno, Nevada, United States
Edison, New Jersey, United States
Teaneck, New Jersey, United States
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