Overview
Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss
Description
Phase 1, open-label, safety and feasibility study of implantation of PF-05206388 (human embryonic stem cell derived retinal pigment epithelium) in subjects with wet age related macular degeneration and rapid vision loss
Eligibility
Inclusion Criteria:
- Male and /or post-menopausal female subjects aged 60 years or above.
- Diagnosis of wet Age-related Macular Degeneration (AMD) plus rapid recent vision decline
- An informed consent document signed and dated by the subject or a legal representative.
Exclusion Criteria:
- Pregnant females; breastfeeding females; and females of childbearing potential.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Current or previous significant other ocular disease in the study eye, as determined by the investigator.