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NCT03597399 · ClinicalTrials.gov registry record
A Patient Registry Study for Patients Treated With Voretigene Neparvovec in US
A clinical trial, sponsored by Spark Therapeutics.
- Completed
- Registry status
- 87
- Enrollment target
NCT03597399: Completed study, sponsored by Spark Therapeutics.
NCT03597399 is a clinical trial that has completed, run by Spark Therapeutics. The registered enrollment target is 87 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03597399 has completed, sponsored by Spark Therapeutics.
- COMPLETED
- Registry status
- 87 participants
- Enrollment target
Study Summary
The objective of this study is to collect long-term safety information (i.e., for 5 years after treatment) associated with voretigene neparvovec-rzyl (vector and/or transgene), its subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products. The enrollment period will last for two years from the first treatment following product approval (through 31March2020) and include a minimum of 40 patients.
Primary Outcome
adverse events
Interventions
- BIOLOGICAL AAV2-hRPE65v2,voretigene neparvovec-rzyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2025-06-30 |
What the finished NCT03597399 record still lists
NCT03597399 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 87 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which AAV2-hRPE65v2,voretigene neparvovec-rzyl is the first listed.
NCT03597399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03597399 about?
NCT03597399 is a clinical study titled "A Patient Registry Study for Patients Treated With Voretigene Neparvovec in US". The objective of this study is to collect long-term safety information (i.e., for 5 years after treatment) associated with voretigene neparvovec-rzyl (vector and/or transgene), its subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and produc...
What is the current status of trial NCT03597399?
This trial is currently completed. The enrollment target is 87 participants. The study started on 2019-01-10. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT03597399?
The interventions under investigation include: AAV2-hRPE65v2,voretigene neparvovec-rzyl (BIOLOGICAL).
Who is sponsoring clinical trial NCT03597399?
This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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