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)

Phase 2

Completed

• Conditions: Non-infectious Uveitis
• Interventions: Combination Product: EYS606

• Registration Number: NCT04207983
• Lead Sponsor: Eyevensys

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.

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Study Start: 2020-02-03
• Primary Completion: 2021-10-05
• Study Completion: 2021-10-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm B (Single administration)	EYS606	One administration of EYS606 (135μg pEYS606/90 μL) at the baseline visit (V1).
Treatment Arm A (Re-administration)	EYS606	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.

Primary Outcome Measures

Name	Time	Method
Time to rescue therapy between the two EYS606 treatment regimens	Week 24	Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606

Secondary Outcome Measures

Name	Time	Method
Median time to control of active CNIU	Each Visit up to Week 48	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	Each Visit up to Week 48	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
Proportion (%) of subjects responded to the treatment	Week 8 and 24	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
Median change in visual acuity	Each Visit up to Week 48	Measured in change from baseline in best-corrected visual acuity using EDTRS
Proportion (%) of subjects achieving and maintaining active chronic noninfectious posterior uveitis (CNIU)	Week 24	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

Trial Locations

Locations (3)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Texas Retina Associates; 🇺🇸 Arlington, Texas, United States