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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) (ELECTRO)

Primary Purpose

Non-infectious Uveitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

EYS606

About this trial

This is an interventional treatment trial for Non-infectious Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Eligibility Criteria:

Subject must be 18 years of age or older.
Subject must have a diagnosis of chronic non-infectious uveitis of any anatomic subtype (anterior, intermediate, posterior or panuveitis).
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.
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).
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.
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).

Sites / Locations

Cleveland Clinic Foundation
Texas Retina Associates
Houston Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment Arm A (Re-administration)

Treatment Arm B (Single administration)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time to rescue therapy between the two EYS606 treatment regimens

Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606

Secondary Outcome Measures

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

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

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

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

Median change in visual acuity

Measured in change from baseline in best-corrected visual acuity using EDTRS

Full Information

NCT ID

NCT04207983

First Posted

December 19, 2019

Last Updated

March 9, 2022

Sponsor

Eyevensys

1. Study Identification

Unique Protocol Identification Number

NCT04207983

Brief Title

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)

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 3, 2020 (Actual)

Primary Completion Date

October 5, 2021 (Actual)

Study Completion Date

October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eyevensys

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-infectious Uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm A (Re-administration)

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment Arm B (Single administration)

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

EYS606

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to rescue therapy between the two EYS606 treatment regimens

Description

Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Proportion (%) of subjects responded to the treatment

Description

Time Frame

Week 8 and 24

Title

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

Description

Time Frame

Week 24

Title

Median time to control of active CNIU

Description

Time Frame

Each Visit up to Week 48

Title

Median time to loss of treatment effect

Description

Time Frame

Each Visit up to Week 48

Title

Median change in visual acuity

Description

Measured in change from baseline in best-corrected visual acuity using EDTRS

Time Frame

Each Visit up to Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Eligibility Criteria: Subject must be 18 years of age or older. Subject must have a diagnosis of chronic non-infectious uveitis of any anatomic subtype (anterior, intermediate, posterior or panuveitis). 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. 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). 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. 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).

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

93309

Country

United States

Facility Name

Texas Retina Associates

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Houston Eye Associates

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30009894

Citation

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.

Results Reference

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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)

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