Clinical trial NCT01691261: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age Related Macular Degeneration
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2012-09-24
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Incidence and severity of adverse events.
timeFrame: 52 weeks
measure: Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24.
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more
timeFrame: Weeks 1,2,4,8, 12,16, 36, 52
measure: Mean change of best corrected visual acuity (BCVA) from baseline by study visit.
timeFrame: 52 weeks
measure: Position of PF-05206388 by serial biomicroscopic evaluation.
timeFrame: Day 2 and Weeks 1, 2, 4, 8, 10, 12, 16, 24, 36, 52
measure: Position and presence of pigmented RPE cells by serial fundus photography
timeFrame: Weeks 2, 4, 8, 10, 12, 16, 24, 36, 52
measure: Mean change from baseline in contrast sensitivity by Pelli Robson test
timeFrame: Weeks 24, 52
measure: Change in liver and renal function by blood tests and liver ultrasound .
timeFrame: Weeks 24 and 52
measure: Change in leakage or perfusion in normal fundal vasculature and presence of abnormal vasculature by fundus fluorescein angiography.
timeFrame: Weeks 4, 8, 12, 24 and 52
measure: Change in central 30 degree of visual function by Humphrey Field test.
timeFrame: Weeks 4, 8, 12, 24 and 52
measure: Change in thickness of RPE layer by B-mode orbital ultrasound.
timeFrame: Weeks 4, 8, 16, 24, 36, 52
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Moorfields
role: STUDY_DIRECTOR
References: