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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)
Trial ID: NCT04207983
The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.
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)
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
- 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
combination product: EYS606
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