A study to look at how safe a study medicine was for patients – when taken at different doses - and how this medicine was processed through the body

Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age‑Related Macular Degeneration (AMD)

  • Eye Disorder
  • Age-Related Macular Degeneration
  • Dry Macular Degeneration
  • Geographic Atrophy
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:

Completed

This study runs in
Cities
  • Asheville
  • Bakersfield
  • Colorado Springs
  • Marietta
  • Melbourne
  • Mountain View
  • Nashville
  • Pensacola
  • Reno
  • Sacramento
  • Santa Barbara
  • Santa Maria
  • St. Louis
Trial Identifier:

NCT03295877 GR39821

  • California Retina Consultants

    5555 Business Park S93309BakersfieldUnited States

  • California Retina Consultants

    525 E Micheltorena St93103Santa BarbaraUnited States

  • California Retina Consultants - Santa Maria

    1510 E Main St93454Santa MariaUnited States

  • Florida Eye Associates

    509 E New Haven Ave32901MelbourneUnited States

  • Georgia Retina PC

    30060MariettaUnited States

  • Northern California Retina Vitreous Associates

    2495 Hospital Dr94040Mountain ViewUnited States

  • Retina Consultants of Southern Colorado PC; Clinical Research Department

    2770 N Union Blvd80909Colorado SpringsUnited States

  • Retina Specialty Institute

    5150 N Davis Hwy32503PensacolaUnited States

  • Retinal Consultants Med Group

    3 Parkcenter Dr95825SacramentoUnited States

  • Sierra Eye Associates

    950 Ryland St89502RenoUnited States

  • Tennessee Retina PC.

    345 23rd Ave N37203NashvilleUnited States

  • The Retina Institute

    12106 Tesson Ferry Rd63128St. LouisUnited States

  • Western Carolina Retinal Associate PA

    21 Medical Park Dr28803AshevilleUnited States
    +−
    Show study locations

    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 Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.

    Genentech, Inc. Sponsor
    Phase 1 Phase
    NCT03295877, GR39821 Study Identifier
    All Gender
    ≥ 50 Years Age
    No Healthy Volunteers

    This was a study to investigate a new medicine (FHTR2163) in patients with an eye disease, called “age-related macular degeneration with geographic atrophy”, or “AMD with GA”. Patients were injected in their eye with different amounts of the study medicine to find the dose that was safe.

    Study Summary

    This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.

    Genentech, Inc. Sponsor
    Phase 1 Phase
    NCT03295877, GR39821 Trial Identifier
    RO7171009 Treatments
    Geographic Atrophy Condition
    Official Title

    A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

    Eligibility Criteria

    All Gender
    ≥ 50 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Participants aged greater than or equal to (>/=) 50 years
    • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye
    Exclusion Criteria

    Ocular Exclusion Criteria, Study Eye:

    • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
    • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
    • Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

    Ocular Exclusion Criteria (Both Eyes):

    • GA in either eye due to causes other than AMD
    • Evidence of prior or active CNV
    • Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months

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

     

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