Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD (PORTRAY)

General Information

Summary To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells.
Description This study will be a Phase 2, double-masked, randomized, parallel group, sham surgery/placebo control, multi-center trial. Subjects will be randomized in a 3:1 ratio to either the treatment or control group respectively. Subjects randomized to the treatment group will receive transplantation with 200,000 MA09-hRPE (human embryonic stem cell derived retinal pigmented epithelial)cells in one eye. Subjects randomized to the control group will have a sham surgery without transplantation of MA09-hRPE cells. The study eye must meet all eligibility criteria. If both eyes meet all eligibility criteria, then the study eye will be the eye with the worst Best Corrected Visual Acuity (BCVA) score at screening. If both eyes have identical BCVA scores, then the study eye will be chosen by the Investigator and the subject. There will be 3 cohorts, each with a different regimen of low-dose IMT [tacrolimus and mycophenolate mofetil (MMF)]. Subjects will be randomized to treatment or control within cohorts, defined by severity of BCVA in the study eye at Screening. Enrollment in Cohort 1 and 2 will be concurrent. Enrollment into Cohort 3 will begin once Cohort 2 is fully enrolled.
Clinical trials phase Phase 2
Start date (estimated) 2015-08-24
End date (estimated) 2017-05-05
Clinical feature
Label atrophic macular degeneration
Link http://www.ebi.ac.uk/efo/EFO_1001492
Description Dry AMD is most common type of macular degeneration and affects 90% of the people who have the condition. In the dry form, there is a breakdown or thinning of the layer of retinal pigment epithelial cells (RPE) in the macula. No medical or surgical treatment is available for this condition.

Administrative Information

NCT Number NCT02563782
Other study identifiers
Name 7317-CL-0002
Name MA09-hRPE AMD 02 PORTRAY
Description ( Other Identifier: Sponsor )
Source weblink https://clinicaltrials.gov/ct2/show/record/NCT02563782
Regulatory body approval
Name Food and Drug Administration (FDA)
Country
United States
Public contact
Country
Sponsors Astellas Pharma Inc.

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Withdrawn