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Safety &Efficacy of CF101 to Subjects With Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01905124
Recruitment Status : Withdrawn (The company has decided not to conduct the study)
First Posted : July 23, 2013
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
Can-Fite BioPharma

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

Condition or disease Intervention/treatment Phase
Uveitis, Posterior Uveitis, Intermediate Drug: CF101 Drug: Placebo Phase 2

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 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Drug: CF101
CF101 1 mg q12 hours
Drug: CF101
CF101 1 mg tablets orally every 12 hours for 24 weeks
Other Name: IB-MECA

Placebo Comparator: Placebo tablets of CF101
Placebo tablets q12 hours
Drug: Placebo
Matching placebo tablets orally every 12 hours for 24 weeks
Other Name: Sugar pills

Primary Outcome Measures :
  1. Severity of uveitis on standardized photographic assessment [ Time Frame: 24 weeks ]
    Standardized fundus photographs will be obtained and uniformly assessed in a masked fashion at the Reading Center

Secondary Outcome Measures :
  1. Safety of CF101 [ Time Frame: 24 weeks ]
    Frequency, nature, and severity of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01905124

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Bnei-Zion Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Can-Fite BioPharma

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Responsible Party: Can-Fite BioPharma Identifier: NCT01905124     History of Changes
Other Study ID Numbers: CF101-241UV
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Can-Fite BioPharma:
Intermediate uveitis
Posterior uveitis
Additional relevant MeSH terms:
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Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroid Diseases