Clincosm LogoSign in Get a demo

Retinal Pigment Epithelium Safety Study For Patients In B4711001

Sponsor
Moorfields Eye Hospital NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT03102138
Collaborator
(none)
2
Enrollment
1
Location
48.4
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2 participants
    Official Title:
    LONG TERM, OPEN-LABEL, SAFETY FOLLOW UP STUDY FOLLOWING TRANSPLANTATION OF PF-05206388 (HUMAN EMBRYONIC STEM CELL DERIVED RETINAL PIGMENT EPITHELIUM (RPE)) IN SUBJECTS WITH ACUTE WET AGE RELATED MACULAR DEGENERATION AND RECENT RAPID VISION DECLINE
    Actual Study Start Date :
    Sep 21, 2016
    Anticipated Primary Completion Date :
    Oct 4, 2020
    Anticipated Study Completion Date :
    Oct 4, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    observation

    subjects treated in B4711001 with PF-05206388 will be assessed

    Outcome Measures

    Primary Outcome Measures

    1. incidence of serious adverse events and ocular adverse events [4 years]

      incidence of serious adverse events and ocular adverse events will be monitored

    Secondary Outcome Measures

    1. Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA) [4 years]

      Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA). The Proportion of subjects with an improvement of 15 letters or more at all timepoints will be assessed

    2. Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints. [4 years]

      Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    • Previous participation in Protocol B4711001 and received treatment with PF-05206388.

    • Subjects who are willing and able to comply with scheduled visits, and study procedures.

    Exclusion Criteria:
    • there are no exclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moorfields Eye Hospital NHS Foundation Trust London United Kingdom EC1V 2PD

    Sponsors and Collaborators

    • Moorfields Eye Hospital NHS Foundation Trust

    Investigators

    • Principal Investigator: Lyndon da Cruz, Moorfields Eye Hospital NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Moorfields Eye Hospital NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03102138
    Other Study ID Numbers:
    • B4711005
    • 2015-002267-42
    First Posted:
    Apr 5, 2017
    Last Update Posted:
    Nov 1, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Nov 1, 2019