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)

Launched by GENENTECH, INC. · Nov 15, 2022

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ClinConnect Summary

The GAlette clinical trial is studying a new treatment called OpRegen for people with geographic atrophy (GA), a condition that can lead to vision loss due to age-related macular degeneration (AMD). This trial aims to see how safely and effectively OpRegen can be delivered directly to the eye through a surgical procedure. Participants will be closely monitored to assess how well the treatment works and whether it is safe to use.

To be eligible for the trial, participants need to be between 18 and 262 years old and have been diagnosed with GA linked to AMD. They must also be able to undergo a specific type of eye surgery and have a certain level of vision in the affected eye. However, people who are pregnant, have certain medical conditions, or specific eye issues may not be able to join. If someone participates, they can expect to undergo a surgical procedure and follow-up assessments to monitor their progress. This study is currently recruiting participants, and it’s a chance to contribute to research that may help others with similar vision challenges.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
• • Diagnosis of GA secondary to AMD
• • BCVA score \>/= 29 letters and \</= 60 letters in the study eye as assessed by 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