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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 15, 2029

Interventions

  • Biological: OpRegen
    • OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space

Arms, Groups and Cohorts

  • Experimental: OpRegen
    • OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with subretinal surgical delivery of OpRegen to target regions
    • Time Frame: 3 months post surgery
  • Incidence and severity of procedure-related adverse events at 3 months following surgery
    • Time Frame: 3 months post surgery

Secondary Measures

  • • Proportion of patients with qualitative improvement in retinal structure, as determined by OCT imaging within 3 months following surgery
    • Time Frame: 3 months post surgery

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care – Diagnosis of GA secondary to AMD – BCVA score >/= 35 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 patient to a significant degree or put the patient 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 patient at high risk for treatment complications

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Reference Study ID Number: GR44251 https://forpatients.roche.com/, 888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com

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