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)

NCT ID: NCT04207983

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2021-10-05

Brief Summary

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

Detailed 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.

Conditions

Non-infectious Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm A (Re-administration)

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.

Group Type: EXPERIMENTAL

EYS606

Intervention Type: COMBINATION_PRODUCT

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

Treatment Arm B (Single administration)

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

Group Type: EXPERIMENTAL

EYS606

Intervention Type: COMBINATION_PRODUCT

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

Interventions

EYS606

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eyevensys

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Texas Retina Associates

Arlington, Texas, United States

Houston Eye Associates

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30009894 (View on PubMed)

Other Identifiers

EYS606-CT2

Identifier Type: -

Identifier Source: org_study_id