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

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
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
Actual Study Start Date :	June 15, 2015
Estimated Primary Completion Date :	November 20, 2018
Estimated Study Completion Date :	November 20, 2018

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 ]
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 ]

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 ]
2. Mean change of best corrected visual acuity (BCVA) from baseline by study visit. [ Time Frame: 52 weeks ]
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 ]
4. Position and presence of pigmented RPE cells by serial fundus photography [ Time Frame: Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52 ]
5. Mean change from baseline in contrast sensitivity by Pelli Robson test [ Time Frame: Weeks 24, 52 ]
6. Change in liver and renal function by blood tests and liver ultrasound . [ Time Frame: Weeks 24 and 52 ]
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 ]
8. Change in central 30 degree of visual function by Humphrey Field test. [ Time Frame: 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Years and older (Adult, Senior)
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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Locations

United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD

Sponsors and Collaborators

Pfizer

University College, London

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01691261 History of Changes
Other Study ID Numbers:	B4711001; 2011-005493-37 ( EudraCT Number )
First Posted:	September 24, 2012
Last Update Posted:	December 21, 2017
Last Verified:	December 2017

Additional relevant MeSH terms:

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases