A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette)

  • Eye Disorder
  • 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:

Recruiting

This study runs in
Countries
  • Israel
  • United States
Study Identifier:

NCT05626114 GR44251

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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 will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT05626114, GR44251 Study Identifier
      OpRegen Treatments
      Geographic Atrophy Condition
      Official Title

      A Phase IIa, Multicenter, Open-Label, Single-Arm Study To Optimize Subretinal Surgical Delivery And To Evaluate Safety And Activity Of Opregen In Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

      Eligibility Criteria

      All Gender
      ≥50 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
      • Diagnosis of GA secondary to AMD
      • BCVA score >/= 29 letters and </= 60 letters in the study eye as assessed by ETDRS
      • Pseudophakic (study eye)
      Exclusion Criteria
      • Pregnancy or breastfeeding
      • History of cognitive impairment or dementia
      • Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk

      Ocular Exclusion Criteria for Study Eye:

      • Any current or history of ocular disease other than GA that may confound assessment of the macula
      • History of retinal detachment
      • History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
      • Uncontrolled glaucoma or advanced glaucoma
      • Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
      • History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
      • Any existing posterior segment device or implant

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

       

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