ClinicalTrials.gg
WithdrawnNCT01905124Updated Feb 1, 2018

Safety &Efficacy of CF101 to Subjects With Uveitis

A Phase 2 interventional study of CF101 and Placebo in Uveitis, Posterior and Uveitis, Intermediate, sponsored by Can-Fite BioPharma. Withdrawn at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Can-Fite BioPharma · Phase 2, Interventional, and Treatment

Why this study was withdrawn
The company has decided not to conduct the study
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Uveitis, Posterior
  • Uveitis, Intermediate

Keywords

  • Uveitis
  • Intermediate uveitis
  • Posterior uveitis
03

In context

Uveitis, Posterior

61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.

Browse Uveitis, Posterior studies →

Lead sponsor

Can-Fite BioPharma is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  1. Ability to understand and provide written .

Exclusion criteria

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 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 -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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Drug: CF101

    CF101 1 mg q12 hours

    Drug: CF101

  • Placebo comparator
    Placebo tablets of CF101

    Placebo tablets q12 hours

    Drug: Placebo

Interventions

  • DrugCF101

    CF101 1 mg tablets orally every 12 hours for 24 weeks

    Also known as: IB-MECA

  • DrugPlacebo

    Matching placebo tablets orally every 12 hours for 24 weeks

    Also known as: Sugar pills

06

What researchers measure

Primary outcomes

  1. Severity of uveitis on standardized photographic assessment

    Standardized fundus photographs will be obtained and uniformly assessed in a masked fashion at the Reading Center

    Time frame: 24 weeks

Secondary outcomes

  1. Safety of CF101

    Frequency, nature, and severity of adverse events

    Time frame: 24 weeks

07

Study locations

1 site
  • Bnei-Zion Medical Center
    Haifa, 31048, Israel
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2019; primary completion for Sep 2019, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2013
First posted
Jul 23, 2013
StartEst.
Jan 2019
Primary completionEst.
Sep 2019
CompletionEst.
Oct 2019
Last update
Feb 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01905124
Lead sponsor
Can-Fite BioPharma
Responsible party
Sponsor
First posted
Jul 23, 2013
Start date
Jan 2019 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Feb 1, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: CF101

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