Trial Profile
A Follow-On Study to Evaluate the Safety of Re-Administration of Adeno-Associated Viral Vector Containing the Gene for Human RPE65 [AAV2-hRPE65v2] to the Contralateral Eye in Subjects With Leber Congenital Amaurosis (LCA) Previously Enrolled in a Phase 1 Study
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 13 Mar 2024
Price :
$35
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At a glance
- Drugs Voretigene neparvovec (Primary)
- Indications Leber congenital amaurosis
- Focus Adverse reactions
- Sponsors Spark Therapeutics
- 10 Mar 2021 Planned End Date changed from 1 Nov 2026 to 1 Jun 2030.
- 10 Mar 2021 Planned primary completion date changed from 1 Nov 2026 to 1 Mar 2030.
- 23 Nov 2018 According to a Novartis media release, the EC decision for approval of Luxturna, is based on a positive CHMP opinion opinion, that looked at the data from a phase 1 clinical trial (NCT00516477), this follow-up trial (NCT01208389) and a phase 3 trial (NCT00999609).