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

Non-infectious Uveitis Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03308045
Study type Interventional
Source Eyevensys
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 4, 2017
Completion date June 1, 2021
View Details
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