Status:
WITHDRAWN
Safety &Efficacy of CF101 to Subjects With Uveitis
Lead Sponsor:
Can-Fite BioPharma
Conditions:
Uveitis, Posterior
Uveitis, Intermediate
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis.
Detailed Description
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 uveit...
Eligibility Criteria
Inclusion
- 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;
- 10\. Ability to understand and provide written informed consent.
Exclusion
- 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;
- Uncontrolled glaucoma or ocular hypertension in either eye, defined as intraocular pressure (IOP) \>21 mm Hg while on medical therapy;
- Chronic hypotony (IOP \<6 mm Hg) in either eye;
- Presence of an ocular implantable steroid-eluting device;
- Ocular injection of corticosteroid within 3 months prior to Baseline;
- Use of Retisert within 6 months prior to baseline;
- Use of the following within 90 days prior to Baseline or anticipated use to either eye during the trial:
- Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors), or
- Posterior subtenon steroids;
- YAG capsulotomy within 30 days prior to Day 1 in the study eye;
- History of herpetic infection in the study eye or adnexa;
- Oral corticosteroid dose \>20 mg/day prednisone equivalent;
- Oral corticosteroid dose has been changed within 2 weeks prior to screening, or is expected to change while on study;
- Systemic immunosuppressive agent dose has been changed within 2 weeks prior to screening;
- Treatment with systemic monoclonal antibody within the longer of 1 month or 5 serum half-lives, prior to screening;
- Diagnosis or history of Behçet's Disease;
- Any significant ocular disease that could compromise vision in either eye, including but not limited to:
- Diabetic retinopathy: proliferative diabetic retinopathy or non-proliferative diabetic retinopathy that compromise vision,
- Wet age-related macular degeneration, and
- Myopic degeneration with active subfoveal choroidal neovascularization.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01905124
Start Date
January 1 2019
End Date
October 1 2019
Last Update
February 1 2018
Active Locations (1)
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1
Bnei-Zion Medical Center
Haifa, Israel, 31048