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

Roche

Status and phase: Completed; Phase 3

Conditions: Wet Macular Degeneration

Treatments: Procedure: Sham Procedure; Drug: Faricimab; Drug: Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT03823287

GR40306

2018-002152-32 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 671 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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671 participants in 2 patient groups

Faricimab

Experimental group

Treatment:

Drug: Faricimab

Procedure: Sham Procedure

Aflibercept

Active Comparator group

Treatment:

Drug: Aflibercept

Procedure: Sham Procedure