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Completed

NCT Number: NCT01691261

A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration

Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss

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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

Interventional

Phase

Phase 1

Primary location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

About this study

Phase 1, open-label, safety and feasibility study of implantation of PF-05206388 (human embryonic stem cell derived retinal pigment epithelium) in subjects with wet age related macular degeneration and rapid vision loss

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and /or post-menopausal female subjects aged 60 years or above.
  • Diagnosis of wet Age-related Macular Degeneration (AMD) plus rapid recent vision decline
  • An informed consent document signed and dated by the subject or a legal representative.

Exclusion criteria

  • Pregnant females; breastfeeding females; and females of childbearing potential.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Current or previous significant other ocular disease in the study eye, as determined by the investigator.

Treatment and study plan

PF-05206388

Biological

PF-05206388 will be provided as a Retinal Pigment Epithelium living tissue equivalent for intraocular use in the form of a monolayer of Retinal Pigmented Epithelial (RPE) cells immobilized on a polyester membrane. The membrane is approximately 6 mm x 3 mm and will contain a confluent layer of RPE cells, at a nominal dose of 17 mm2. The implant is intended to be life-long.

Primary outcomes

  1. Incidence and severity of adverse events.

    Time frame: 52 weeks

    The number of Adverse Events (AE) and Serious Adverse Events (SAE) noted during the study and an assessment of whether they are trial product related

  2. Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24.

    Time frame: 24 weeks

    The number of patients with a difference between the baseline BCVA and BCVA at 24 weeks in ETDRS letters, where the differences is 15 letters or more, as a percentage of the total number of cases.

Secondary outcomes

  1. Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more

    Time frame: Weeks 1,2,4,8, 12,16, 36, 52

    The number of patients with a difference between the baseline BCVA and BCVA at weeks 1,2,4,8, 12,16, 36, 52 in ETDRS letters, where the differences is 15 letters or more, as a percentage of the total number of cases.

  2. Mean change of best corrected visual acuity (BCVA) from baseline by study visit.

    Time frame: 52 weeks

    The mean difference between the baseline BCVA and final BCVA in ETDRS letters for all cases

  3. Position of PF-05206388 by serial biomicroscopic evaluation.

    Time frame: Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52

    Measurement of movement in millimetre and rotation in degrees measure relative to baseline, at day 2 and weeks 1, 2, 4, 8, 10, 12, 16, 24, 36 and 52

  4. Position and presence of pigmented RPE cells by serial fundus photography

    Time frame: Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52

    The subjective reporting of area of pigmentation as a % with cross reference to the OCT at weeks 2, 4, 8, 10, 12, 16, 24, 36 and 52

  5. Mean change from baseline in contrast sensitivity by Pelli Robson test

    Time frame: Weeks 24, 52

    The mean difference between the baseline BCVA and final BCVA in Pelli Robson letters read, across all subjects

  6. Change in liver and renal function by blood tests and liver ultrasound .

    Time frame: Weeks 24 and 52

    Record of any abnormalities in liver and renal function on blood testing and any abnormalities detected on the liver ultrasound.

  7. Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography.

    Time frame: Weeks 4, 8, 12, 24 and 52

    Assessment and noting of abnormalities on Funded fluorescine angiography at weeks 4, 8, 12, 24 and 52.

  8. Change in central 30 degree of visual function by Humphrey Field test.

    Time frame: Weeks 4, 8, 12, 24 and 52

    Recording and reporting of any changes on the central 30 degree field on the automated Humphrey Field test at weeks 4, 8, 12, 24 and 52

  9. Change in thickness of RPE layer by B-mode orbital ultrasound.

    Time frame: Weeks 4, 8, 16, 24, 36, 52

    Recording of any changes in thickness of RPE layer by B-mode orbital ultrasound carried out by the ocular oncologist or medical physicist at weeks 4, 8, 16, 24, 36, 52.

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • University College, London

Registry information

Official study title

Phase 1, Open-label, Safety and Feasibility Study of Implantation of Pf-05206388 (human Embryonic Stem Cell Derived Retinal Pigment Epithelium (rpe) Living Tissue Equivalent) in Subjects with Acute Wet Age Related Macular Degeneration and Recent Rapid Vision Decline

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 24, 2012
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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