A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa
Not yet recruiting
Phase of Trial: Phase I/II
Latest Information Update: 09 Apr 2018
At a glance
- Drugs GS 030 (Primary)
- Indications Retinitis pigmentosa
- Focus Adverse reactions; First in man
- Acronyms PIONEER
- Sponsors GenSight Biologics
- 05 Apr 2018 Planned initiation date changed from 1 Jan 2018 to 1 May 2018.
- 10 Jan 2018 According to a GenSight Biologics media release, The primary outcome analysis will be the safety and tolerability at one year post-injection, and company expects to treat the first patient in the United Kingdom in the first quarter of 2018.
- 10 Jan 2018 According to GenSight Biologics media release, UK Medicines and Healthcare Regulatory Agency (MHRA) has accepted Clinical Trial Application (CTA) to initiate this trial.