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

Fecha de inicio: 1 de enero de 2019

Inclusion Criteria: 1. Male or female, 18 years of age and over; 2. Diagnosis of active, sight-threatening, noninfectious intermediate or posterior uveitis, as determined by the Standardization of Uveitis Nomenclature (SUN) Working Group Criteria. 3. Vitreous haze in at least 1 eye (the "study eye") of ≥Grade 3 on the "Miami Scale" at the Screening Visit, as confirmed by the Uveitis Photograph Reading Center; , 4. Best corrected visual acuity (BCVA) in the poorer seeing eye of 1.3 logarithm of the minimum angle of resolution (logMAR) or better by Early Treatment Diabetic Retinopathy Study (ETDRS; equivalent to 20/400) at Screening; 5. Requires, in the judgment of the Investigator, systemic therapy to treat uveitis; 6. No plans for elective ocular surgery during the trial duration; 10\. Ability to understand and provide written informed consent. Exclusion Criteria: 1. Primary diagnosis of anterior uveitis; 2. Uveitis of infectious etiology; 3. Presence of chorioretinal scars that are highly suspicious for ocular toxoplasmosis; 4. Confirmed or suspected uveitis of traumatic etiology; 5. Clinically suspected or confirmed central nervous system or ocular lymphoma; 6. Presence of any other form of ocular malignancy in the either eye including choroidal melanoma; 7. Corneal or lens opacities or obscured ocular media other than vitreous haze upon enrollment such that reliable clinical evaluations and grading of the posterior segment cannot be performed; 8. Pupillary dilation inadequate for quality fundus photography; 9. Uncontrolled glaucoma or ocular hypertension in either eye, defined as intraocular pressure (IOP) \>21 mm Hg while on medical therapy; 10. Chronic hypotony (IOP \<6 mm Hg) in either eye; 11. Presence of an ocular implantable steroid-eluting device; 12. Ocular injection of corticosteroid within 3 months prior to Baseline; 13. Use of Retisert within 6 months prior to baseline; 14. Use of the following within 90 days prior to Baseline or anticipated use to either eye during the trial: 1. Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors), or 2. Posterior subtenon steroids; 15. YAG capsulotomy within 30 days prior to Day 1 in the study eye; 16. History of herpetic infection in the study eye or adnexa; 17. Oral corticosteroid dose \>20 mg/day prednisone equivalent; 18. Oral corticosteroid dose has been changed within 2 weeks prior to screening, or is expected to change while on study; 19. Systemic immunosuppressive agent dose has been changed within 2 weeks prior to screening; 20. Treatment with systemic monoclonal antibody within the longer of 1 month or 5 serum half-lives, prior to screening; 21. Diagnosis or history of Behçet's Disease; 22. Any significant ocular disease that could compromise vision in either eye, including but not limited to: 1. Diabetic retinopathy: proliferative diabetic retinopathy or non-proliferative diabetic retinopathy that compromise vision, 2. Wet age-related macular degeneration, and 3. Myopic degeneration with active subfoveal choroidal neovascularization.