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

Moorfields Eye Hospital NHS Foundation Trust

Status and phase: Enrolling; Phase 1

Conditions: Age Related Macular Degeneration

Treatments: Biological: PF-05206388

Study type: Interventional

Funder types: Other

Identifiers

NCT01691261

B4711001

2011-005493-37 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

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

Treatment:

Biological: PF-05206388