A clinical trial to compare faricimab with aflibercept in people with neovascular age-related macular degeneration. (Tenaya)

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

  • Eye Disorder
  • Wet Age-Related Macular Degeneration
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Boisbriand
  • Calgary
  • London
  • Ottawa
  • Sherbrooke
  • Toronto
  • Vancouver
Trial Identifier:

NCT03823287 2018-002152-32 GR40306

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03823287,GR40306,2018-002152-32 Trial Identifier
      Faricimab, Aflibercept, Sham Procedure Treatments
      Wet Macular Degeneration Condition
      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)

      Eligibility Criteria

      All Gender
      ≥50 Years Age
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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