The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Clinical diagnosis of dry AMD.
Ability to understand and give informed consent.
Adult male or female >55 years of age.
Medically suitable to undergo vitrectomy and subretinal injection (>60% on Karnofsky scale).
Allergy or hypersensitivity to dilation drops or fluorescein.
Active major medical conditions limiting ability to participate in the study.
Active malignancy or treatment with chemotherapy.
Systemic immunosuppressant therapy within past six months.
Sequential
RPESC-RPE-4W
Biological/VaccineRPESC-RPE-4W
Safety and tolerability of RPESC-RPE-4W transplantation
The transplantation of RPESC-RPE-4W cells will be considered safe and tolerated in the absence of: * Decrease in visual acuity (VA) of more than 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (or to worse than counting fingers at three feet) from baseline * Any Grade 2 (CTCAE v5.0) or greater non-ocular Adverse Events (AE) related to the RPESC-RPE-4W investigational product (IP) or investigational interventions * Intraocular inflammation indicating contamination with an infectious agent or serious immune response greater than moderate severity related to the RPESC-RPE-4W investigational product or investigational interventions * Tumor formation \> 1 mm size related to the IP or investigational interventions
Change in the mean of Best Corrected Visual Acuity (BCVA)
Change in visual acuity will be measured by ETDRS chart.
Loss of ≥10 decibels of ten-degree average visual sensitivity microperimetry
Loss of ≥10 decibels of ten-degree average visual sensitivity will by measured by microperimetry.
Change in GA lesion area
Change in GA lesion area will be measured.
Evidence of structural changes
Structural evidence will be measured by OCT imaging, autofluorescence, fluorescein angiography, and fundus photography
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Luxa Biotechnology, LLC
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Eye Institute (NEI)
Collaborator
Regenerative Research Foundation
Collaborator
California Institute for Regenerative Medicine (CIRM)
Collaborator
