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

NCT02563782 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-07-26

No results posted yet for this study

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.

Conditions

  • Age-Related Macular Degeneration

Interventions

BIOLOGICAL

Sub-retinal transplantation of MA09-hRPE cells

transplantation

DRUG

tacrolimus and mycophenolate mofetil

Immunosuppressive Agents

DRUG

Placebo tacrolimus and mycophenolate mofetil

placebo

PROCEDURE

Sham Surgery

Sham surgery

Sponsors & Collaborators

  • Astellas Institute for Regenerative Medicine

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Institute for Regenerative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2017-05-05
Completion
2017-05-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563782 on ClinicalTrials.gov