A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A regiszterben nem jelölt feltételek

• Eligible participants include:
• Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
• Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 15.0 mm2 of geographic atrophy involving the fovea.
• Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
• The best-corrected visual acuity (BCVA) of the eye to receive the implant will be ≥20/200 (35 EDTRS letters) to 20/63 (60 EDTRS letters) inclusive. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant.
• Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required.
• Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
• Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
• Participants also must be willing and able to provide written, signed informed consent for this study.
• Participants able to complete the baseline microperimetry retinal sensitivity testing.
• On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.