Optimizing surgical delivery of OpRegen for geographic atrophy in AMD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of a surgical method for delivering OpRegen in patients suffering from geographic atrophy due to age-related macular degeneration. Participants will undergo a vitreoretinal surgical procedure, and the study will assess the outcomes based on visual acuity and other clinical endpoints. The focus is on determining how well the treatment works and its safety profile in this specific patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Retina-Vitreous Associates Medical Group
  Beverly Hills, California, United States Recruiting
• Retinal Consultants Medical Group
  Sacramento, California, United States Recruiting
• West Coast Retina
  San Francisco, California, United States Recruiting
• Retina Vitreous Associates of Florida
  St. Petersburg, Florida, United States Recruiting
• The Retina Care Center
  Baltimore, Maryland, United States Recruiting
• The Retina Institute
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GR44251 https://forpatients.roche.com/ No attachments to email below
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Central microperimetry and radial OCT in geographic atrophy

  We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.

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• One-time intravitreal SAR446597 injection for geographic atrophy due to AMD

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• Dapagliflozin (an SGLT2 inhibitor) for slowing geographic atrophy in dry AMD

  This trial will test whether taking dapagliflozin once daily can slow the growth of geographic atrophy in people aged 50 and older with dry age-related macular degeneration.

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• Eye injections of ABBV-6628 for geographic atrophy from age-related macular degeneration

  This trial will test whether intravitreal ABBV-6628 is safe and how the drug moves through the body in adults aged 50 and older with geographic atrophy from AMD.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.