A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

Trial Profile

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
  • Most Recent Events

    • 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.
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