This study is accepting new patients by invitation only

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

a study on Macular Degeneration

Summary

for people ages 50 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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). The global enrollment phase has closed, but participants are still being recruited only at sites in Japan.

Official Title

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)

Keywords

Wet Macular Degeneration AMD nAMD neovascular age-related macular degeneration choroidal neovascularization secondary to age-related macular degeneration Macular Degeneration Faricimab Aflibercept

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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 CAN'T join 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

Locations

  • Jacobs Retina center at the Shiley eye Institute UCSD
    La Jolla California 92037 United States
  • Retina Consultants, San Diego
    Poway California 92064 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03823287
Phase
Phase 3
Study Type
Interventional
Last Updated