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

Primary Purpose

Age Related Macular Degeneration

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
PF-05206388
Sponsored by
Moorfields Eye Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moorfields Eye Hospital NHS Foundation TrustRecruiting
  • Moorfields Eye Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more
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.
Mean change of best corrected visual acuity (BCVA) from baseline by study visit.
The mean difference between the baseline BCVA and final BCVA in ETDRS letters for all cases
Position of PF-05206388 by serial biomicroscopic evaluation.
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
Position and presence of pigmented RPE cells by serial fundus photography
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
Mean change from baseline in contrast sensitivity by Pelli Robson test
The mean difference between the baseline BCVA and final BCVA in Pelli Robson letters read, across all subjects
Change in liver and renal function by blood tests and liver ultrasound .
Record of any abnormalities in liver and renal function on blood testing and any abnormalities detected on the liver ultrasound.
Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography.
Assessment and noting of abnormalities on Funded fluorescine angiography at weeks 4, 8, 12, 24 and 52.
Change in central 30 degree of visual function by Humphrey Field test.
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
Change in thickness of RPE layer by B-mode orbital ultrasound.
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.

Full Information

First Posted
September 19, 2012
Last Updated
August 18, 2022
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT01691261
Brief Title
A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
March 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
PF-05206388
Intervention Description
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 Outcome Measure Information:
Title
Incidence and severity of adverse events.
Description
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
Time Frame
52 weeks
Title
Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24.
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more
Description
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.
Time Frame
Weeks 1,2,4,8, 12,16, 36, 52
Title
Mean change of best corrected visual acuity (BCVA) from baseline by study visit.
Description
The mean difference between the baseline BCVA and final BCVA in ETDRS letters for all cases
Time Frame
52 weeks
Title
Position of PF-05206388 by serial biomicroscopic evaluation.
Description
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
Time Frame
Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52
Title
Position and presence of pigmented RPE cells by serial fundus photography
Description
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
Time Frame
Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52
Title
Mean change from baseline in contrast sensitivity by Pelli Robson test
Description
The mean difference between the baseline BCVA and final BCVA in Pelli Robson letters read, across all subjects
Time Frame
Weeks 24, 52
Title
Change in liver and renal function by blood tests and liver ultrasound .
Description
Record of any abnormalities in liver and renal function on blood testing and any abnormalities detected on the liver ultrasound.
Time Frame
Weeks 24 and 52
Title
Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography.
Description
Assessment and noting of abnormalities on Funded fluorescine angiography at weeks 4, 8, 12, 24 and 52.
Time Frame
Weeks 4, 8, 12, 24 and 52
Title
Change in central 30 degree of visual function by Humphrey Field test.
Description
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
Time Frame
Weeks 4, 8, 12, 24 and 52
Title
Change in thickness of RPE layer by B-mode orbital ultrasound.
Description
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.
Time Frame
Weeks 4, 8, 16, 24, 36, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania West
Phone
02072533411
Ext
2036
Email
moorfields.resadmin@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Narvaez
Phone
02072533411
Ext
2036
Email
moorfields.resadmin@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moorfields
Organizational Affiliation
Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moorfields R&D
Phone
020 7253 3411
Ext
2937
Email
moorfields.resadmin@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4711001&StudyName=A%20Study%20Of%20Implantation%20Of%20Human%20Embryonic%20Stem%20Cell%20Derived%20Retinal%20Pigment%20Epithelium%20In%20Subjects%20With%20Acute%20Wet%20Age%20Related%20Macular
Description
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A Study Of Implantation Of Retinal Pigment Epithelium In Subjects With Acute Wet Age Related Macular Degeneration

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