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 range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.