A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration

Last updated: November 19, 2024
Sponsor: Moorfields Eye Hospital NHS Foundation Trust
Overall Status: Completed

Phase

1

Condition

Geographic Atrophy

Macular Degeneration

Treatment

PF-05206388

Clinical Study ID

NCT01691261
DACL1010
2011-005493-37
  • Ages > 60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 visiondecline

  • An informed consent document signed and dated by the subject or a legalrepresentative.

Exclusion

Exclusion Criteria:

  • Pregnant females; breastfeeding females; and females of childbearing potential.

  • Treatment with an investigational drug within 30 days (or as determined by the localrequirement, whichever is longer) or 5 half-lives preceding the first dose of studymedication.

  • Current or previous significant other ocular disease in the study eye, as determinedby the investigator.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: PF-05206388
Phase: 1
Study Start date:
October 14, 2021
Estimated Completion Date:
June 24, 2024

Study 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

Connect with a study center

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Site Not Available

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