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

NCT ID: NCT01691261

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2024-06-24

Brief Summary

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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

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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

Conditions

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Age Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PF-05206388

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moorfields

Role: STUDY_DIRECTOR

Moorfields Eye Hospital NHS Foundation Trust

Locations

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Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

Other Identifiers

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2011-005493-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DACL1010

Identifier Type: -

Identifier Source: org_study_id

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