A 48 Week Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)

Non-infectious Uveitis Clinical Trial

— ELECTRO  

Official title:

A 48 Week Phase II, Randomized, Open-Label, Multicenter, Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207983
• Other study ID #: EYS606-CT2
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2020
• Est. completion date: October 5, 2021

Study information

• Verified date: March 2022
• Source: Eyevensys
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.

Description:

This is a Phase 2, multi-center, randomized open-label interventional study of EYS606 in subjects with active chronic non-infectious uveitis.

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 will be conducted in 2 parts. Part I is a safety cohort phase that will enroll up to 6 subjects, Part II is the randomized comparison phase that will enroll up to an additional 50 subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Eligibility Criteria:

1. Subject must be 18 years of age or older.

2. Subject must have a diagnosis of chronic non-infectious uveitis of any anatomic subtype (anterior, intermediate, posterior or panuveitis).

3. Subject must have a history of chronic or recurrent non-infectious uveitis requiring or having required treatment with corticosteroids (systemic, periocular or intraocular) and/or systemic immunosuppressive medication(s) in the 12 months prior to the screening visit.

4. Best corrected visual acuity of

• Study Part I: = 5 and < 67 ETDRS letters in the study eye (equivalent to less than or equal to 20/50 but better than or equal to 20/800 Snellen).

• Study Part II: = 5 and < 77 ETDRS letters in the study eye (equivalent to less than or equal to 20/32 but better than or equal to 20/800 Snellen).

5. At the screening and baseline visits subject must have active chronic non-infectious uveitis as evidenced by at least one or more of the following in the study eye:

• Active retinal vasculitis (retinal vascular leakage) involving the posterior pole confirmed by the reading center.

• Vitreous haze grade = 2+ (SUN classification).

• Anterior chamber cell grade = 2+ (SUN classification); anterior chamber cells must be present for subjects with a diagnosis of chronic anterior non-infectious uveitis.

• Persistent macular edema (defined as central retinal thickness (CRT) > 300 microns or > 320 microns using Zeiss Cirrus and Topcon or Heidelberg Spectralis spectral domain ocular coherence tomography (SD-OCT) instruments, respectively) despite treatment with corticosteroids and/or immunosuppressive therapy for at least 4 weeks prior to screening.

6. Subject receiving concomitant topical and/or systemic corticosteroids or allowed systemic immunosuppressive medications must have maintained the same treatment regimen (dosage/frequency) for at least 2 weeks prior to the baseline (V1) visit, (if applicable).

Related Conditions & MeSH terms

• Non-infectious Uveitis
• Uveitis

Intervention

Combination Product:
• EYS606
EYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle

Locations

Country	Name	City	State
United States	Texas Retina Associates	Arlington	Texas
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Houston Eye Associates	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eyevensys

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to rescue therapy between the two EYS606 treatment regimens	Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606	Week 24
Secondary	Proportion (%) of subjects responded to the treatment	Measured as an improvement in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, central retinal thickness using ocular coherence tomography, and an increase in visual acuity using EDTRS compared to baseline	Week 8 and 24
Secondary	Proportion (%) of subjects achieving and maintaining active chronic noninfectious posterior uveitis (CNIU)	Measured as an improvement in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, central retinal thickness using ocular coherence tomography, and an increase in visual acuity using EDTRS compared to baseline	Week 24
Secondary	Median time to control of active CNIU	Measured as an improvement in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, and central retinal thickness using ocular coherence tomography	Each Visit up to Week 48
Secondary	Median time to loss of treatment effect	Measured as an worsening in anterior cell grade and vitreous haze grade according to the SUN scale, retinal vessel leakage using fluorescein angiography, central retinal thickness using ocular coherence tomography, decrease in visual acuity using EDTRS, and any increase in the frequency of dose of specified concomitant medications	Each Visit up to Week 48
Secondary	Median change in visual acuity	Measured in change from baseline in best-corrected visual acuity using EDTRS	Each Visit up to Week 48