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); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251

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.

The substudy will evaluate the operational feasibility and scientific interpretability of incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.

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
Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (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

Substudy:

Inclusion Criteria:

- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol

Exclusion Criteria:

Participants who meet any exclusion criteria listed in the parent study GR44251
Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood