A Study Of Implantation Of Human Embryonic Stem Cell Derived Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration And Recent Rapid Vision Decline

General Information

Summary 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.
Clinical trials phase Phase 1
Start date (estimated) 2015-06-15
End date (estimated) 2019-06-01
Clinical feature
Label wet macular degeneration
Link http://www.ebi.ac.uk/efo/EFO_0004683
Description A form of RETINAL degeneration in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.; A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.

Administrative Information

NCT Number NCT01691261
EudraCT Number 2011-005493-37
Other study identifiers
Name B4711001
Regulatory body approval
Name Medicines & Healthcare products Regulatory Agency (MHRA)
Country
United Kingdom
Public contact
Country
Sponsors Pfizer
Collaborators

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Active, not recruiting
Estimated number of participants 2