The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
EYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Texas Retina Associates
Arlington, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Time to rescue therapy between the two EYS606 treatment regimens
Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606
Time frame: Week 24
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
Time frame: Week 8 and 24
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
Time frame: Week 24
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
Time frame: Each Visit up to Week 48
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
Time frame: Each Visit up to Week 48
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Median change in visual acuity
Measured in change from baseline in best-corrected visual acuity using EDTRS
Time frame: Each Visit up to Week 48