A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Last updated: March 28, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

4

Condition

Geographic Atrophy

Macular Degeneration

Treatment

Faricimab

Clinical Study ID

NCT06795048
MR45638
2024-517545-13-00
  • Ages > 50
  • All Genders

Study Summary

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Overtly healthy as determined by medical evaluation that includes medical historyand physical examination

  • Agreement to adhere to the contraception requirements described in the protocol

Ocular Inclusion Criteria for Study Eye:

  • Active treatment-naïve macular neovascularization (MNV) secondary to age-relatedmacular degeneration (AMD), confirmed by the investigator based on the presence ofintraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield onoptical coherence tomography (OCT)

  • BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent,using the early treatment diabetic retinopathy study [ETDRS] protocol and addressedat the initial testing distance of 4 meters on Day 1)

  • Sufficiently clear ocular media and adequate pupillary dilation to allow acquisitionof good quality retinal images to confirm diagnosis

Exclusion

Exclusion Criteria:

Ocular Exclusion Criteria for Study Eye:

  • MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma,pathological myopia, angioid streaks, choroidal rupture, or uveitis

  • Retinal pigment epithelial tear involving the macula on Day 1

  • Current vitreous hemorrhage on Day 1

  • Prior periocular pharmacological or IVT treatment (including faricimab,anti-vascular endothelial growth factor [VEGF], or complement inhibitor medication)for other retinal diseases

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

  • Participants who have a nonfunctioning fellow (non-study) eye, defined as eitherBCVA of hand motion or worse, or no physical presence of non-study eye (i.e.,monocular), at both the screening and study Day 1 visits

Ocular Exclusion for Both Eyes:

  • History of idiopathic or autoimmune associated uveitis in either eye

  • Active ocular inflammation or suspected or active ocular or periocular infection ineither eye on study Day 1

Study Design

Total Participants: 274
Treatment Group(s): 1
Primary Treatment: Faricimab
Phase: 4
Study Start date:
March 14, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Strathfield Retina Clinic

    Strathfield, New South Wales 2135
    Australia

    Active - Recruiting

  • Retina Institute of Ottawa

    Ottawa, Ontario K2B 7E9
    Canada

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • Ctr for Retina & Macular Dis

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Active - Recruiting

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