The Safety and Tolerability of Sub-retinal Transplantation of SCNT-hES-RPE Cells in Patients With… (NCT03305029) | Clinical Trial Compass
UnknownPhase 1
The Safety and Tolerability of Sub-retinal Transplantation of SCNT-hES-RPE Cells in Patients With Advanced Dry AMD
South Korea3 participantsStarted 2016-05
Plain-language summary
To evaluate the safety and tolerability of human somatic cell nuclear transfer embryonic stem cell derived retinal pigmented epithelial(SCNT-hES-RPE) cellular therapy in patients with advanced dry AMD
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Adult male or female over 50 years of age.
✓. Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
✓. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of \>250 microns of geographic atrophy (as defined in the Age-Related eye Disease Study \[AREDS\] study) involving the central fovea.
✓. GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
✓. The visual acuity (BCVA) of the eye to receive the transplant will be no better than 20/200 in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity.
✓. The visual acuity (BCVA) of the eye that is NOT to receive the transplant will be same or better than the eye to receive the transplant
✓. Medically suitable to undergo vitrectomy and subretinal injection.
✓. Medically suitable for general anesthesia or waking sedation, if needed.
Exclusion criteria
✕. Presence of active or inactive CNV in the eye to be treated.
✕. Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy, other retinal vascular or degenerative disease other than ARMD, optic neuropathy, uveitis, intraocular inflammatory disease, retinal detachment repair or any other sight-threatening ocular disease.
. Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
✕. Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
✕. Axial myopia of greater than -8 diopters.
✕. Axial length greater than 28 mm.
✕. Presence of significant lens opacities or other media opacity.
✕. History of ocular lens removal within previous 3 months in the study eye.