Retinal Pigment Epithelium Safety Study For Patients In B4711001

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03102138
• Other study ID #: B4711005
• Secondary ID: 2015-002267-42
• Status: Not yet recruiting
• Start date: January 21, 2024
• Est. completion date: May 30, 2033

Study information

• Verified date: November 2023
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: Declan Flanagan
• Phone: 07872414988
• Email: moorfields.resadmin[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 30, 2033
• Est. primary completion date: May 30, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust, 162 City Road	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of serious adverse events and ocular adverse events	incidence of serious adverse events and ocular adverse events will be monitored	4 years
Secondary	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
Secondary	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

External Links

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