RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-03-23
Study Completion:2031-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05626114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
  2. * Diagnosis of GA secondary to AMD
  3. * BCVA score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)
  4. * Pseudophakic (study eye)
  1. * Pregnancy or breastfeeding
  2. * History of cognitive impairment or dementia
  3. * 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
  4. * Any current or history of ocular disease other than GA that may confound assessment of the macula
  5. * History of retinal detachment
  6. * History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
  7. * Uncontrolled glaucoma or advanced glaucoma
  8. * Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
  9. * 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
  10. * Any existing posterior segment device or implant

Contacts and Locations

Study Contact

Reference Study ID Number: GR44251 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
Retinal Consultants Medical Group
Sacramento, California, 95825
United States
West Coast Retina
San Francisco, California, 94109-5520
United States
The Retina Care Center
Baltimore, Maryland, 21209-2219
United States
The Retina Institute
St Louis, Missouri, 63128-1729
United States
Cincinnati Eye Institute
Blue Ash, Ohio, 45242-5537
United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107-5109
United States
Tennessee Retina PC
Nashville, Tennessee, 37203-1513
United States
Austin Clinical Research, LLC
Austin, Texas, 78750-2298
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502-4271
United States
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-23
Study Completion Date2031-03-01

Study Record Updates

Study Start Date2023-03-23
Study Completion Date2031-03-01

Terms related to this study

Keywords Provided by Researchers

  • Geographic Atrophy secondary to Age-related Macular Degeneration

Additional Relevant MeSH Terms

  • Geographic Atrophy