Retinal Pigment Epithelium Safety Study For Patients In B4711001

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Age Related Macular Degeneration

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Declan Flanagan; Phone Number: 07872414988; Email: moorfields.resadmin@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with AMD treated in main study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
observation; subjects treated in B4711001 with PF-05206388 will be assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of serious adverse events and ocular adverse events	incidence of serious adverse events and ocular adverse events will be monitored	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA)	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	4 years
Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints.	Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints will be assessed	4 years

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): January 21, 2024
• Primary Completion (Estimated): May 30, 2033
• Study Completion (Estimated): May 30, 2033

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: B4711005; 2015-002267-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.