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NCT02563782 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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