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

Recruiting in Palo Alto (17 mi)
+179 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Hoffmann-La Roche
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

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
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Treatment Details

Interventions

  • Aflibercept (Monoclonal Antibodies)
  • Faricimab (Monoclonal Antibodies)
  • Sham Procedure (Procedure)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: FaricimabExperimental Treatment2 Interventions
Group II: AfliberceptActive Control2 Interventions

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Florida Eye AssociatesMelbourne, FL
Retina Vit Surgeons/Central NYLiverpool, NY
Ophthalmic Cons of Long IslandOceanside, NY
Midwest Vision Research FoundationChesterfield, MO
More Trial Locations
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Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2482
Patients Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek