The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
RPESC-RPE-4W is Allogeneic RPE stem cell (RPESC)-derived RPE cells (RPESC-RPE) isolated from the RPE layer of human cadaveric eyes are transplanted under the macular. This first-in-human Phase 1/2a open-label dose-escalation interventional study plans to enroll a total of 18 subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
RPESC-RPE-4W
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
RECRUITINGSpencer Center for Vision Research
Palo Alto, California, United States
RECRUITINGUniversity of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States
RECRUITINGSafety 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
Time frame: 24 months
Change in the mean of Best Corrected Visual Acuity (BCVA)
Change in visual acuity will be measured by ETDRS chart.
Time frame: 24 months
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.
Time frame: 24 months
Change in GA lesion area
Change in GA lesion area will be measured.
Time frame: 24 months
Evidence of structural changes
Structural evidence will be measured by OCT imaging, autofluorescence, fluorescein angiography, and fundus photography
Time frame: 24 months
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