Exudative age related macular degeneration
Conditions
Interventions
The size of the RPE sheet used in the first 3 cases will be 1.3 mm x 3 mm
In the 3 following cases, the use of RPE sheets of a larger size, or of in multiple number with the same size, will be allowed
Sponsors
RIKEN
Foundation for Biomedical Research and Innovation Kobe City Medical Center general Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of exudative AMD including non-typical subtypes in at least one eye. 2) Male and female subjects aged 50 year and older at the time of acquired consent 3) Presence of subfoveal CNV, fibrotic scar, or RPE tear related to exudative AMD 4) The visual acuity of less than 0.3 but better than hand motion. 5) Treatment history of standard anti-VEGF therapy with limited effects such as poor response or persistent recurrence (minimum treatment with anti-VEGF induction therapy followed by at least one additional injection) 6) The mean Central 4-degree retinal sensitivity of less than 5 db on MicroPerimeter1 (MP-1) examination 7) Able to understand and willing to sign the informed consent
Exclusion criteria
Exclusion criteria: 1) Presence of ocular infection 2) Presence of other retinal diseases such as diabetic retinopathy, hypertensive retinopathy, retinal vessel occlusions. 3) Presence of optic nerve atrophy 4) Presence of glaucoma of uncontrolled ocular pressure 5) Presence of significant hepatic failure (with either AST or ALT higher than 100 IU/L) 6) Presence of renal failure 7) Negative serum tests for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) or syphilis. 8)No history of allergic reaction to antibiotics or bovine serum 9) No medical requirements for a continuous treatment of anti-coagulants or anti-platelets 10) Medically suitable for general anesthesia 11) No presence of or history of malignancy in past 5 years 12) No history of allergic reaction to ICG or Fluorescein 13) Pregnant females; breastfeeding females; and females of childbearing potential. 14) No participation in other clinical trials that involve the last one month before informed consent is obtained 15) Medically judged inadequate by the docters responsible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the proposed treatment protocol: incidence and severity of adverse events related to the use of autologous iPSC derived RPE sheet. <Adverse events related to iPSC derived RPE sheet> 1 Poor survival of the graft, immune rejection 2 Tumor formation <Adverse events related to surgical procedure> 1. Retinal detachment, choroidal hemorrhage, vitreous hemorrhage 2 Retinal tear and retinal detachment | — |
Countries
Japan
Contacts
Public ContactYasuhiko Hirami
Kobe City Medical Center General Hospital Department of Ophthalmology
Outcome results
None listed