Neovascular age related macular degeneration
Conditions
Interventions
Subretinal transplantation of allogenic iPSC derived RPE cells
Sponsors
Kobe City Eye Hospital
1.Osaka University Hospital 2.Center for iPS Cell Research and Application 3.RIKEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) At least one eye has been diagnosed with wet AMD (including PCV and RAP) 2) Men and women 50 years of age and more, 85 years of age and less 3) Presence of subfoveal lesions of any of CNV, fibrotic scar, RPE atrophy or RPE tear without surgically removable lesions 4) Corrected visual acuity not less than hand motion and less than 0.3 5) The eye has relapse or incomplete resolution of exudative changes after receiving at least one additional anti-VEGF agent following 3 injections of induction therapy (total of at least 4 injections) or anti-VEGF agent is considered ineffective for exudative changes. 6) With or without dye leakage by fluorescein angiography 7) Well understood and written informed consent has been obtained from the patient. 8) Matched with HLA haplotype A*24:02-C*12:02-B*52:01-DRB1*15:02-DQB1*06:01-DPB1*09:01
Exclusion criteria
Exclusion criteria: (1)-4) applicable only in subject eye) 1) Ocular infection 2) Other retinal disease (diabetic retinopathy, hypertensive retinopathy, vascular occlusion, etc.) 3) Optic nerve atrophy 4) Glaucoma with poorly controled intraocular pressure 5) Severe liver dysfunction (AST/ALT 100 IU/L or higher) 6) Severe renal impairment that require dialysis 7) Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus, Adult T-cell Leukemia Virus, cases of Syphilis-positive 8) Allergic to bovine serum or antibiotics (penicillin, streptomycin) 9) Unable to quit anti-coagulants or anti-platelet medication 10) Malignant carcinoma (except for carcinoma in situ) or its history in the past 3 years 11) Allergic to fluorescein or indocyanine green angiography 12) Possible pregnancy or with the partner having a wish for pregnancy 13) Enrolled in another clinical study in the past 1 month 14) Judged unsuitable for study participation by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of the investigational treatment: the presence or absence, severity and frequency of each of the following adverse events (AE) due to the iPS cell-derived RPE cell transplantation surgery. [Adverse events associated with the iPSC-derived RPE cells] 1. Graft failure, immune rejection 2. Excessive proliferation or tumorigenesis by the graft cells [Adverse events associated with the transplantation surgery or its procedure] 1. Retinal, choroidal or vitreous hemorrhage 2. Retinal detachment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Safety The severity and frequency of AEs other than those described above and are associated with iPSC derived RPE cells. The severity and frequency of AEs other than those described above and are associated with the transplantation surgery or its procedure. The severity, frequency, and type of all AEs (based on the CTCAE v4.0-JCOG) other than those described above. (2) Efficacy - Foveal retinal thickness, subretinal fluid, retinal edema by OCT. - Retinal sensitivity accessed by multi-local ERG and microperimetry . - Visual acuity. - The dye leakage of CNV by fluorescence angiography - The interval period until next treatment of anti-VEGF drugs because of the recurrence of CNV and the anti-VEGF drug treatment times during 1 year from the RPE cell transplantation. - Change in QOL. | — |
Countries
Japan
Contacts
Public ContactNaoki Shibatani
Kobe City Eye Hospital Research Center
Outcome results
None listed