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A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01691261
Recruitment Status : Not yet recruiting
First Posted : September 24, 2012
Last Update Posted : September 22, 2021
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Biological: PF-05206388 Phase 1

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
PF-05206388 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
 Biological: PF-05206388
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events. [ Time Frame: 52 weeks ]
    The number of Adverse Events (AEs) and Serious Adverse Events SAEs 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 Outcome Measures :
  1. Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an impovement 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 fluorescing 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 degreee 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691261


Contacts
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Contact: Tania West moorfields.resadmin@nhs.net

Locations
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United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
University College, London
Investigators
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Study Director: Moorfields Moorfields Eye Hospital NHS Foundation Trust
More Information
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Additional Information:

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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01691261    
Other Study ID Numbers: B4711001
2011-005493-37 ( EudraCT Number )
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases