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)

Last updated: July 4, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

OpRegen

Clinical Study ID

NCT05626114
GR44251
  • Ages > 50
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to undergo a vitreoretinal surgical procedure under monitored anesthesiacare

  • 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

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, orchange to such an extent that it may bias the assessment of the clinical status ofthe 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 assessmentof 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 subretinalsurgical delivery of OpRegen

  • History of other ocular or intraocular conditions that contraindicate the use of aninvestigational drug or may affect interpretation of the study results or may renderthe participant at high risk for treatment complications

  • Any existing posterior segment device or implant

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: OpRegen
Phase: 2
Study Start date:
March 23, 2023
Estimated Completion Date:
March 01, 2031

Connect with a study center

  • Hadassah MC

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah MC; Ophtalmology

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95825
    United States

    Active - Recruiting

  • West Coast Retina

    San Francisco, California 94109-5520
    United States

    Active - Recruiting

  • Mid Atlantic Retina

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Blue Ash, Ohio 45242-5537
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107-5109
    United States

    Active - Recruiting

  • Austin Clinical Research, LLC

    Austin, Texas 78750-2298
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

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