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)

Phase 2

Recruiting

• Conditions: Geographic Atrophy
• Interventions: Biological: OpRegen

• Registration Number: NCT05626114
• Lead Sponsor: Genentech, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Study Start: 2023-03-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2031-03-01
• Study Completion: 2031-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OpRegen	OpRegen	OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Procedure-related Adverse Events at 3 Months Following Surgery	3 months post surgery
Proportion of Patients With Subretinal Surgical Delivery of OpRegen to Target Regions	3 months post surgery

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Qualitative Improvement in Retinal Structure, as Determined by OCT Imaging Within 3 Months Following Surgery	3 months post surgery

Trial Locations

Locations (7)

Hadassah MC; 🇮🇱 Jerusalem, Israel

Tel Aviv Sourasky MC; 🇮🇱 Tel Aviv, Israel

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

West Coast Retina; 🇺🇸 San Francisco, California, United States

Cincinnati Eye Institute; 🇺🇸 Blue Ash, Ohio, United States

Mid Atlantic Retina; 🇺🇸 Philadelphia, Pennsylvania, United States