Trial Search Results

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)

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eyevensys

Stanford Investigator(s):

Intervention(s):

  • Combination Product: EYS606

Phase:

Phase 2

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).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting