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 trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT03295877 GR39821

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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 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
      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.

      Trial 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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