Uveitis, Posterior Clinical Trial
Official title:
A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Daily CF101 Administered Orally to Subjects With Active, Sight-Threatening, Noninfectious Intermediate or Posterior Uveitis
This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis.
This is a Phase 2, randomized, double-masked, placebo-controlled study in adult males and
females, aged 18 years and over, with active, sight-threatening, noninfectious intermediate
or posterior uveitis. Subjects will be randomly assigned to receive CF101 1 mg or matching
placebo tablets in a 2:1 ratio orally every 12 hours for 24 weeks.
At the Screening Visit (performed within 4 weeks prior to Baseline), subjects who provide
written informed consent will have a complete medical history, medication history, physical
examination, weight, sitting blood pressure, pulse rate, temperature, electrocardiogram
(ECG), clinical laboratory tests, and ophthalmologic examination, including biomicroscopy and
grading of uveitis activity. For assessment of uveitis activity and response to treatment,
fundus photography will be obtained according to a standardized procedure and interpreted at
the Uveitis Photograph Reading Center.
Subjects who successfully qualify will begin dosing with CF101 1 mg or placebo, to be taken
orally every 12 hours for 24 weeks. At the Baseline Visit, a PBMC sample will be obtained for
assessment of A3AR expression level. Subjects will return for safety and efficacy assessments
and a new supply of study medication at Weeks 2, 4, 8, 12, 16, 20, and for final assessment
and discharge at Week 24. A telephone call to each subject will be made at Week 26, for the
purpose of collecting information on adverse events (AEs) and concomitant medications.
During the course of the trial, concomitant use of intraocular or posterior subtenon
corticosteroids, intravitreal injections (including but not limited to steroids or
anti-vascular endothelial growth factors), systemic corticosteroids at a dose >20 mg/day
prednisone equivalent, or monoclonal antibody therapy is prohibited. Systemic corticosteroid
and immunosuppressive regimens must remain stable throughout the course of the trial.
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