NCT05626114

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
59mo left

Started Mar 2023

Longer than P75 for phase_2

Geographic Reach
2 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Mar 2023Mar 2031

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

7.9 years

First QC Date

November 15, 2022

Last Update Submit

April 19, 2026

Conditions

Geographic Atrophy

Keywords

Geographic Atrophy Secondary to Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

OpRegen

EXPERIMENTAL

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

Biological: OpRegen

Interventions

OpRegenBIOLOGICAL

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

OpRegen

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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:
  • Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

RECRUITING

West Coast Retina

San Francisco, California, 94109-5520, United States

RECRUITING

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

RECRUITING

The Retina Care Center

Baltimore, Maryland, 21209-2219, United States

RECRUITING

The Retina Institute

St Louis, Missouri, 63128-1729, United States

RECRUITING

Sierra Eye Associates

Reno, Nevada, 89502-1605, United States

RECRUITING

Duke Eye Center

Durham, North Carolina, 27705-4699, United States

RECRUITING

Cincinnati Eye Institute

Blue Ash, Ohio, 45242-5537, United States

RECRUITING

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107-5109, United States

RECRUITING

Tennessee Retina PC

Nashville, Tennessee, 37203-1513, United States

RECRUITING

Austin Clinical Research, LLC

Austin, Texas, 78750-2298, United States

RECRUITING

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

RECRUITING

Piedmont Eye Center

Lynchburg, Virginia, 24502-4271, United States

RECRUITING

Spokane Eye Clinical Research;Spokane Eye Surgery Center

Spokane, Washington, 99204, United States

RECRUITING

Hadassah MC

Jerusalem, 9112001, Israel

RECRUITING

Tel Aviv Sourasky MC

Tel Aviv, 6423906, Israel

RECRUITING

Related Publications (1)

  • Aweidah H, Matsevich C, Khaner H, Idelson M, Ejzenberg A, Reubinoff B, Banin E, Obolensky A. Survival of Neural Progenitors Derived from Human Embryonic Stem Cells Following Subretinal Transplantation in Rodents. J Ocul Pharmacol Ther. 2023 Jun;39(5):347-358. doi: 10.1089/jop.2022.0161. Epub 2023 May 4.

    PMID: 37140896DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GR44251 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

March 23, 2023

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations

US(15)IL(2)