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)

NCT04207983 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: EYS606-CT2
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Non-infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion (%) of subjects responded to the treatment

  Week 8 and 24

• Proportion (%) of subjects achieving and maintaining active chronic noninfectious posterior uveitis (CNIU)

  Week 24

• Median time to control of active CNIU

  Each Visit up to Week 48

• Median time to loss of treatment effect

  Each Visit up to Week 48

• Median change in visual acuity

  Each Visit up to Week 48

Study Arms (2)

Treatment Arm A (Re-administration)

EXPERIMENTAL

Two administrations of EYS606 (135μg pEYS606/90 μL). The frequency between the two administrations will be determined by the DSMB upon completion of the Part I safety cohorts.

Combination Product: EYS606

Treatment Arm B (Single administration)

EXPERIMENTAL

One administration of EYS606 (135μg pEYS606/90 μL) at the baseline visit (V1).

Combination Product: EYS606

Interventions

EYS606 COMBINATION_PRODUCT

EYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle

Treatment Arm A (Re-administration); Treatment Arm B (Single administration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eyevensys: lead

Study Sites (3)

Cleveland Clinic Foundation

Cleveland, Ohio, 93309, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Related 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.

  PMID: 30009894 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part I (Safety cohort phase) - no randomization will take place; subjects will be consecutively assigned to one of two sequential safety cohort Regimens and receive two administrations of EYS606 Part II (Randomized comparison phase) - 1:1 randomization to either Treatment Arm A (Regimen 1 or 2 based upon recommendation by the DSMB, n=25) or Treatment Arm B (Regimen 3, n=25)

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: February 3, 2020
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)