Safety &Efficacy of CF101 to Subjects With Uveitis

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Can-Fite BioPharma

Criteria

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.