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

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01691261
• Other study ID #: B4711001
• Secondary ID: 2011-005493-37
• Status: Recruiting
• Phase: Phase 1
• Start date: October 14, 2021
• Est. completion date: March 14, 2024

Study information

• Verified date: August 2022
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: Tania West
• Phone: 02072533411
• Email: moorfields.resadmin[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 14, 2024
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	52 weeks
Primary	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.	24 weeks
Secondary	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.	Weeks 1,2,4,8, 12,16, 36, 52
Secondary	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	52 weeks
Secondary	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	Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52
Secondary	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	Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52
Secondary	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	Weeks 24, 52
Secondary	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.	Weeks 24 and 52
Secondary	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.	Weeks 4, 8, 12, 24 and 52
Secondary	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	Weeks 4, 8, 12, 24 and 52
Secondary	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.	Weeks 4, 8, 16, 24, 36, 52

External Links

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