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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Genentech, Inc.
Study ID
NCT05626114
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 23, 2023
Status verified
May 2026
Primary completion
Mar 1, 2031
Completion
Mar 1, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions [ Time Frame: 3 months post-surgery ]

Central Contacts

  • Reference Study ID Number: GR44251 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]

Locations (15)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Retinal Consultants Medical GroupSacramentoCalifornia95825-
West Coast RetinaSan FranciscoCalifornia94109-5520-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-1141-
The Retina Care CenterBaltimoreMaryland21209-2219-
The Retina InstituteSt LouisMissouri63128-1729-
Sierra Eye AssociatesRenoNevada89502-1605-
Duke Eye CenterDurhamNorth Carolina27705-4699-
Cincinnati Eye InstituteBlue AshOhio45242-5537-
Mid Atlantic RetinaPhiladelphiaPennsylvania19107-5109-
Tennessee Retina PCNashvilleTennessee37203-1513-
Austin Clinical Research, LLCAustinTexas78750-2298-
Retina Consultants of TexasBellaireTexas77401-
Piedmont Eye CenterLynchburgVirginia24502-4271-
Spokane Eye Clinical Research;Spokane Eye Surgery CenterSpokaneWashington99204-

Find similar trials in Beverly Hills, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CARetinal Consultants Medical Group· Sacramento, CAWest Coast Retina· San Francisco, CARetina Vitreous Associates of Florida· St. Petersburg, FLThe Retina Care Center· Baltimore, MDThe Retina Institute· St Louis, MO

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