Retinal Pigment Epithelium Safety Study for Patients in B4711001

N/AActive Not RecruitingNCT03102138

Moorfields Eye Hospital NHS Foundation Trust10 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Age Related Macular Degeneration

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, London, United Kingdom

Outcomes

Primary Outcomes

incidence of serious adverse events and ocular adverse events

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

Time frame: 4 years

Secondary Outcomes

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

Time frame: 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

Time frame: 4 years

Data from ClinicalTrials.gov

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