A PhaseI/IIa Study to Determine the Safety and Tolerability of MA09-hRPE Cells in Patients With A… (NCT01674829) | Clinical Trial Compass
TerminatedPhase 1/2
A PhaseI/IIa Study to Determine the Safety and Tolerability of MA09-hRPE Cells in Patients With Advanced Dry AMD
Stopped: Sponsor decision
South Korea10 participantsStarted 2012-09
Plain-language summary
To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry AMD To evaluate the safety of the surgical procedures when used to implant MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of MA09-hRPE cellular therapy.
Who can participate
Age range55 Years
SexALL
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Inclusion Criteria:
* Adult male or female over 55 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
* GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
* No evidence of current or prior choroidal neovascularization in the treated eye
* The visual acuity (BCVA) of the eye to receive the transplant found to be eligible for trial based on study protocol
* Electrophysiological findings consistent with advanced dry AMD.
* Medically suitable to undergo vitrectomy and subretinal injection.
* Medically suitable for general anesthesia or waking sedation, if needed.
* Medically suitable for transplantation of an embryonic stem cell line
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 or other retinal vascular or degenerative disease other than ARMD.
* History of optic neuropathy.
* Macular atrophy due to causes other than AMD.
* 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.
* History of retinal …