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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05626114

Enrollment

Registered

2022-11-23

Start date

2023-03-23

Completion date

2031-03-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

Keywords

Geographic Atrophy Secondary to Age-related Macular Degeneration

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. 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.

Interventions

BIOLOGICALOpRegen

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions	3 months post-surgery
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery	3 months post-surgery

Secondary

Measure	Time frame
Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery	3 months post-surgery

Countries

Israel, United States

Contacts

CONTACTReference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below

global-roche-genentech-trials@gene.com888-662-6728 (U.S. Only)

CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026