Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis
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ClinicalTrials.gov Identifier: NCT03308045 |
Recruitment Status :
Completed
First Posted : October 12, 2017
Last Update Posted : March 10, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | March 31, 2017 | ||||
First Posted Date ICMJE | October 12, 2017 | ||||
Last Update Posted Date | March 10, 2022 | ||||
Actual Study Start Date ICMJE | April 4, 2017 | ||||
Actual Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of patients with treatment emergent adverse events [ Time Frame: 4 weeks ] Assessment of the safety and tolerability of EYS606
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis | ||||
Official Title ICMJE | 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 | ||||
Brief 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 |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Clinical trial with a single arm Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Non-infectious Uveitis | ||||
Intervention ICMJE | Biological: pEYS606
pEYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle
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Study Arms ICMJE | Experimental: pEYS606
Cohort 1 (pEYS606 lower dose); Cohort 2 (pEYS606 intermediate dose); Cohort 3 (pEYS606 higher dose); Extension Cohort (pEYS606 maximum tolerated dose)
Intervention: Biological: pEYS606
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Publications * | Touchard E, Benard R, Bigot K, Laffitte JD, Buggage R, Bordet T, Behar-Cohen F. Non-viral ocular gene therapy, pEYS606, for the treatment of non-infectious uveitis: Preclinical evaluation of the medicinal product. J Control Release. 2018 Sep 10;285:244-251. doi: 10.1016/j.jconrel.2018.07.013. Epub 2018 Aug 1. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
15 | ||||
Original Estimated Enrollment ICMJE |
24 | ||||
Actual Study Completion Date ICMJE | June 1, 2021 | ||||
Actual Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Visual Criteria - Part 1 (enrolment is Part 1 is completed) - BCVA of 0.1 (ETDRS of 35) or worse at screening in the treated eye, and BCVA of 0.32 or higher in the fellow eye. Key Inclusion Criteria - Part 2 (enrolment in Part 2 is ongoing)
oActive retinal vasculitis (retinal vascular leakage) oVitreous haze grade ≥ 2+ oAnterior chamber cell grade ≥ 2+ oMacular edema
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France, United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03308045 | ||||
Other Study ID Numbers ICMJE | EYS606-CT1 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Eyevensys | ||||
Original Responsible Party | EYEVENSYS S.A.S. | ||||
Current Study Sponsor ICMJE | Eyevensys | ||||
Original Study Sponsor ICMJE | EYEVENSYS S.A.S. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Eyevensys | ||||
Verification Date | March 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |