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)

Not Recruiting

Trial ID: NCT04207983

Purpose

The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.

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)

Stanford Investigator(s)

Quan Dong Nguyen, MD, MSc
Quan Dong Nguyen, MD, MSc

Professor of Ophthalmology and, by courtesy, of Pediatrics and of Medicine (Immunology & Rheumatology)

Eligibility


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).

Intervention(s):

combination product: EYS606

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305