Clareo Health | 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
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
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CONTACT
Lead
Genentech, Inc.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
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:
Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood
