WithdrawnPhase 2

Safety &Efficacy of CF101 to Subjects With Uveitis

Stopped: The company has decided not to conduct the study

Israel0Started 2019-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, 18 years of age and over;
✓. Diagnosis of active, sight-threatening, noninfectious intermediate or posterior uveitis, as determined by the Standardization of Uveitis Nomenclature (SUN) Working Group Criteria.
✓. 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; ,
✓. 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;
✓. Requires, in the judgment of the Investigator, systemic therapy to treat uveitis;
✓. No plans for elective ocular surgery during the trial duration;

Exclusion criteria

✕. Primary diagnosis of anterior uveitis;
✕. Uveitis of infectious etiology;
✕. Presence of chorioretinal scars that are highly suspicious for ocular toxoplasmosis;
✕. Confirmed or suspected uveitis of traumatic etiology;
✕. Clinically suspected or confirmed central nervous system or ocular lymphoma;
✕. Presence of any other form of ocular malignancy in the either eye including choroidal melanoma;
✕. 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;
✕. Pupillary dilation inadequate for quality fundus photography;

What they're measuring

Severity of uveitis on standardized photographic assessment

Timeframe: 24 weeks

Trial details

NCT IDNCT01905124

SponsorCan-Fite BioPharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09

View on ClinicalTrials.gov More Uveitis, Posterior trials