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NCT Number: NCT05626114

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

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.

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah MC, Jerusalem, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OpRegen

Biological

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

Primary outcomes

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

    Time frame: 3 months post-surgery

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

    Time frame: 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

    Time frame: 3 months post-surgery

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Nov 23, 2022
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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