Non-infectious Uveitis
Conditions
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.
Interventions
COMBINATION_PRODUCTEYS606
EYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle
Sponsors
Eyevensys
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Median change in visual acuity | Each Visit up to Week 48 | Measured in change from baseline in best-corrected visual acuity using EDTRS |
Countries
United States
Outcome results
None listed