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)

Genentech

Status and phase: Enrolling; Phase 2

Conditions: Geographic Atrophy

Treatments: Biological: OpRegen

Study type: Interventional

Funder types: Industry

Identifiers

NCT05626114

GR44251

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

OpRegen

Experimental group

Description:

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

Treatment:

Biological: OpRegen