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NCT02463344 · ClinicalTrials.gov registry record
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD
A clinical trial of Age-related Macular Degeneration, sponsored by Astellas Institute for Regenerative Medicine.
- Completed
- Registry status
- 11
- Enrollment target
- 4
- Study locations
NCT02463344: Completed study of Age-related Macular Degeneration, sponsored by Astellas Institute for Regenerative Medicine.
NCT02463344 is a study of Age-related Macular Degeneration that has completed, run by Astellas Institute for Regenerative Medicine. The registered enrollment target is 11 participants, below the 1,508-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02463344, a study of Age-related Macular Degeneration, has completed, sponsored by Astellas Institute for Regenerative Medicine.
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.
Primary Outcome
This will include obtaining information about ophthalmological findings and Serious Adverse Events (SAEs) that are neurologic, infectious, hematologic or fatal, pregnancy in a female subject or the partner of a male subject and pregnancy outcome, any Adverse Event (AE) that causes a subject to withdraw from the study, any new diagnosis of an ocular or immune-mediated disorder, cancer, ectopic or proliferative cell growth (Retinal pigment epithelium (RPE) or non-RPE) with adverse clinical consequ
Conditions Studied
Interventions
- BIOLOGICAL MA09-hRPE
Study Locations (4)
California
- Jules Stein Eye Institute, UCLA School of Medicine - Los Angeles
Florida
- Bascom Palmer Eye Institute - Miami
Massachusetts
- Mass Eye and Ear - Boston
Pennsylvania
- Wills Eye Institute-Mid Atlantic Retina - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-02-25 |
| Est. Completion | 2019-08-19 |
What the finished NCT02463344 record still lists
NCT02463344 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,508-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which MA09-hRPE is the first listed.
NCT02463344 reports a single indexed study location in California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02463344 about?
NCT02463344 is a clinical study titled "Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD". The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.
What is the current status of trial NCT02463344?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2013-02-25. Estimated completion is 2019-08-19.
What conditions does trial NCT02463344 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT02463344?
The interventions under investigation include: MA09-hRPE (BIOLOGICAL).
Who is sponsoring clinical trial NCT02463344?
This trial is sponsored by Astellas Institute for Regenerative Medicine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02463344 being conducted?
This trial has 4 study locations across California, Florida, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02463344's enrollment target sits among peer trials
11 71st of 74 higher than 3 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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