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OpenTrials
Active, Not Recruiting

NCT Number: NCT03102138

Retinal Pigment Epithelium Safety Study for Patients in B4711001

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. incidence of serious adverse events and ocular adverse events

    Time frame: 4 years

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

Secondary outcomes

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

    Time frame: 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.

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 5, 2017
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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