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

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

Not yet recruiting

This study runs in
N/A
Trial Identifier:

NCT06795048 2024-517545-13-00 MR45638

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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 study 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

      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.

      Hoffmann-La Roche Sponsor
      Phase 4 Phase
      NCT06795048, MR45638, 2024-517545-13-00 Trial Identifier
      Faricimab Treatments
      Neovascular Age-related Macular Degeneration (nAMD) Condition
      Official Title

      A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration

      Eligibility Criteria

      All Gender
      ≥50 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Overtly healthy as determined by medical evaluation that includes medical history and 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-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical 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 addressed at the initial testing distance of 4 meters on Day 1)
      • Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
      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 either BCVA 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 in either eye on study Day 1

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