A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy.

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

  • Eye Disorder
  • Dry Macular Degeneration
  • Geographic Atrophy
Please note that the recruitment status of the trial at your site may differ.
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT04615325 GR42163

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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 multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04615325,GR42163 Trial Identifier
      RO7303359 Treatments
      Geographic Atrophy Condition
      Official Title

      A Phase 1a, Multicenter, Open-label, Single-dose, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

      Eligibility Criteria

      All Gender
      ≥50 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Ocular Inclusion Criteria Study Eye:

      • Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters
      • Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)
      • GA area must be >/= 0.5 disc area (1.25 mm^2)

       

      Exclusion Criteria

      Ocular Exclusion Criteria, Study Eye:

      • GA in the study eye due to causes other than AMD
      • 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 photodynamic therapy, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

      Ocular Exclusion Criteria, Both eyes:

      • 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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