B4711005 Stem cell transplantation in wet AMD - Safety follow-up Study
Long-term, open-label, safety follow-up study following transplantation ofPF-05206388 (human embryonic stem cell derived retinal pigment epithelium (RPE) in subjects with acute wet age-related macular degeneration and recent rapid vision decline
Lyndon da Cruz
Moorfields Eye Hospital NHS Foundation Trust
Duration of Study in the UK
4 years, 3 months, 1 days
Subjects who have completed 1 year follow up in B4711001 are invited to take part in this protocol. B4711001 involves administration of a PF-05206388 (consisting of Retinal Pigment Epithelial (RPE) cells on a polyester membrane) to subjects with Age Related Macular Degeneration (AMD). These RPE cells are derived from human embryonic stem cells, and because of the novelty of this approach it is considered prudent to follow these subjects for an extended period.
The purpose of this research study is assess the long term safety and effectiveness of RPE implant PF-05206388. Subjects will not receive any study drug in this study. Instead they will be monitored for the long term effects of the study drug they received in clinical study B4711001.
There are two subjects in the B4711001 study and only 2 subjects will be followed up on the B4711005 study due to Pfizer no longer funding the study. The study is being done at one research site in one country. Participants will be in this study for about 4 years and will need to visit the research site at least seven times during the study.
London - West London & GTAC Research Ethics Committee
Date of REC Opinion
2 Jun 2016
Further Information Favourable Opinion