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Geographic AtrophyPhase 2NCT05626114

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 2 study testing OpRegen in people with Geographic Atrophy, run by Genentech, Inc. at 17 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
OpRegen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
17 sitesin 2 countries
Study dates
23 Mar 2023to 1 Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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:
  • 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

Trial locations and contacts

17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

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

17 sites in 2 countries

United States15 sites, 15 recruiting

  • Austin Clinical Research, LLC

    Austin, Texas, 78750-2298

    Recruiting

  • The Retina Care Center

    Baltimore, Maryland, 21209-2219

    Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

    Recruiting

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

    Recruiting

  • Cincinnati Eye Institute

    Blue Ash, Ohio, 45242-5537

    Recruiting

  • Duke Eye Center

    Durham, North Carolina, 27705-4699

    Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502-4271

    Recruiting

  • Tennessee Retina PC

    Nashville, Tennessee, 37203-1513

    Recruiting

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107-5109

    Recruiting

  • Sierra Eye Associates

    Reno, Nevada, 89502-1605

    Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California, 95825

    Recruiting

  • West Coast Retina

    San Francisco, California, 94109-5520

    Recruiting

  • Spokane Eye Clinical Research;Spokane Eye Surgery Center

    Spokane, Washington, 99204

    Recruiting

  • The Retina Institute

    St Louis, Missouri, 63128-1729

    Recruiting

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711-1141

    Recruiting

Other trials in United States

Israel2 sites, 2 recruiting

  • Hadassah MC

    Jerusalem, 9112001

    Recruiting

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

About this study

Official title: 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

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.

Being tested
OpRegen
Keywords
Geographic Atrophy Secondary to Age-related Macular Degeneration
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpRegenBiological

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

Study groups in NCT05626114
Study groupRoleWhat they receive
OpRegenExperimentalOpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Receives: Biological: OpRegen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions

    Measured: 3 months post-surgery

  2. Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery

    Measured: 3 months post-surgery

Secondary outcomes (1)

  1. Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery

    Measured: 3 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start23 Mar 2023
  3. Primary completion1 Mar 2031 (estimated)
  4. Study completion1 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626114
Sponsor's protocol ID
GR44251
Status last verified
Oct 2026
First submitted
15 Nov 2022
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 37140896

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OpRegen in people with Geographic Atrophy, run by Genentech, Inc. at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions (time frame: 3 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626114, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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