Vision improvement in retinal degeneration patients by implantation of retina together with retinal pigment epithelium.
OBJECTIVE
To demonstrate efficacy and safety of the implantation of neural retinal progenitor cell layers (sheets) with its retinal pigment epithelium (RPE) in retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD) patients with 20/200 or worse vision in the surgery eye.


METHODS
Interventional nonrandomized clinical trial.


METHODS
Ten patients (six RP, four AMD) received retinal implants in one eye and were followed in a phase II trial conducted in a clinical practice setting. Early Treatment Diabetic Retinopathy Study (EDTRS) was the primary outcome measure. All implant recipients and nine of 10 tissue donors were deoxyribonucleic acids typed.


RESULTS
Seven patients (three RP, four AMD) showed improved EDTRS visual acuity (VA) scores. Three of these patients (one RP, two AMD) showed improvement in both eyes to the same extent. Vision in one RP patient remained the same, while vision in two RP patients decreased. One RP patient has maintained an improvement in vision from 20/800 to 20/200 ETDRS for more than five years; at the six-year examination, it was still maintained at 20/320 while the nonsurgery eye had deteriorated to hand motion vision. This patient also showed a 22.72% increase in light sensitivity at five years compared to microperimetry results at two years; the other patients showed no improved sensitivity. Although no match was found between donors and recipients, no rejection of the implanted tissue was observed clinically.


CONCLUSIONS
Seven (70%) of 10 patients showed improved VA. This outcome provides clinical evidence of the safety and beneficial effect of retinal implants and corroborates results in animal models of retinal degeneration.
Retina Vitreous Resource Center, University of Louisville, Louisville, Kentucky, USA. nradtke@rvrc.com
Norman D
ND
Radtke
Robert B
RB
Aramant
Heywood M
HM
Petry
Parke T
PT
Green
Diane J
DJ
Pidwell
Magdalene J
MJ
Seiler
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016172:DNA Fingerprinting; D004596:Electroretinography; D016332:Fetal Tissue Transplantation; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006085:Graft Survival; D006680:HLA Antigens / Q000235:genetics; D006650:Histocompatibility Testing; D006801:Humans; D008268:Macular Degeneration / Q000503:physiopathology / Q000601:surgery*; D008875:Middle Aged; D010857:Pigment Epithelium of Eye / Q000637:transplantation*; D012160:Retina / Q000637:transplantation*; D012174:Retinitis Pigmentosa / Q000503:physiopathology / Q000601:surgery*; D014019:Tissue Donors; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology
D006680:HLA Antigens