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)

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

Conditions

Geographic Atrophy

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Study Overview

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Study Details

Study overview

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

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

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)

Condition
Geographic Atrophy
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States, 90211

Sacramento

Retinal Consultants Medical Group, Sacramento, California, United States, 95825

San Francisco

West Coast Retina, San Francisco, California, United States, 94109-5520

Cincinnati

Cincinnati Eye Institute, Cincinnati, Ohio, United States, 45242

Philadelphia

Mid Atlantic Retina, Philadelphia, Pennsylvania, United States, 19038

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
  • * Diagnosis of GA secondary to AMD
  • * BCVA score \>/= 35 letters and \</= 60 letters in the study eye as assessed by ETDRS
  • * Pseudophakic (study eye)
  • * 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 patient to a significant degree or put the patient at special risk
  • * 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 patient at high risk for treatment complications

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2029-04-11