NCT03308045

Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis

A Phase I/II, Open-label, Multicentre, Dose Escalation Study Assessing Safety/Tolerability of pEYS606 When Administered by Electrotransfer (ET) in Ciliary Muscle of Patients With Non-infectious Posterior, Intermediate or Panuveitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Eyevensys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: safety and tolerability Secondary objectives: additional indicators of long term safety and indicators of clinical activity Exploratory objectives: to characterize EYS606 biodistribution, immunogenicity and biomarkers

Detailed description

The maximum study duration per patient is 51 Weeks (including an up to 3 week screening period + 48 weeks follow-up after treatment). The study is conducted in 2 parts. Part 1 is a dose escalation phase which will investigate three pEYS606 doses levels (lower, intermediate and higher dose) over 3 cohorts. Part 1 of the study has been completed. Part 2, the extension phase, which is now ongoing will confirm to safety of the maximum tolerated higher dose from Part 1 and allow a preliminary assessment of efficacy.

Conditions

• Non-infectious Uveitis

Interventions

Type	Name	Description
BIOLOGICAL	pEYS606	pEYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle

Timeline

• Start date: 2017-04-04
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2017-10-12
• Last updated: 2022-03-10

Locations

4 sites across 2 countries: France, United Kingdom