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) |
2021-10-14 |
| End date (estimated) |
2024-03-14 |
| Clinical feature |
| Label |
age related macular degeneration |
| Link |
http://purl.obolibrary.org/obo/DOID_10871 |
| Description |
A degeneration of macula and posterior pole that is characterized by a loss of vision in the center of the visual field (the macula) resulting from damage to the retina and resulting in blurring of the sharp central vision.; OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT01691261 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01691261 |
| EudraCT number |
2011-005493-37 |
| Other study identifiers |
|
| Source weblink |
http://www.clinicaltrials.gov/ct2/show/NCT01691261 |
| Regulatory body approval |
| Name |
Medicines & Healthcare products Regulatory Agency (MHRA) |
| Country |
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| Study sites |
|
| Public contact |
| Email |
ClinicalTrials.gov_Inquiries@pfizer.com |
| Public email |
moorfields.resadmin@nhs.net |
| First name |
Tania |
| Last name |
West |
| Phone |
+44 20725334112036 |
| Country |
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| Sponsors |
Moorfields Eye Hospital NHS Foundation Trust
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| Collaborators |
|
Cells |
| Source pluripotent stem cell lines |
|
| Which differentiated cell type is used |
| Label |
retinal pigment epithelial cell |
| Link |
http://purl.obolibrary.org/obo/CL_0002586 |
| Description |
An epithelial cell of the retinal pigmented epithelium. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
10 |
| Contact institutions/departments |
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