Uveitis, PosteriorPhase 2NCT01905124
Safety &Efficacy of CF101 to Subjects With Uveitis
A Phase 2 study testing CF101 in people with Uveitis, Posterior and Uveitis, Intermediate, run by Can-Fite BioPharma at 1 site in Israel.
Trial summary
This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Posterior, Uveitis, Intermediate
- What is being tested?
- CF101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2019to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate
- Being tested
- CF101, Placebo
- Keywords
- Uveitis, Intermediate uveitis, Posterior uveitis
- Medical subject headings
- Uveitis, Posterior, Uveitis, Intermediate, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF101Drug
Also called IB-MECA
CF101 1 mg tablets orally every 12 hours for 24 weeks
PlaceboDrug
Also called Sugar pills
Matching placebo tablets orally every 12 hours for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drug: CF101 | Experimental | CF101 1 mg q12 hours Receives: Drug: CF101 |
| Placebo tablets of CF101 | Placebo comparator | Placebo tablets q12 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of uveitis on standardized photographic assessment
Standardized fundus photographs will be obtained and uniformly assessed in a masked fashion at the Reading Center
Measured: 24 weeks
Secondary outcomes (1)
Safety of CF101
Frequency, nature, and severity of adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: The company has decided not to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can-Fite BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905124
- Sponsor's protocol ID
- CF101-241UV
- Status last verified
- Jan 2018
- First submitted
- 14 Jul 2013
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01905124
- Acronym / sponsor ID
- CF101-241UV
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate
- Keywords
- Uveitis, Intermediate uveitis, Posterior uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company has decided not to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Can-Fite BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: CF101 | Experimental | Drug: CF101CF101 1 mg q12 hours |
| Placebo tablets of CF101 | Placebo comparator | Drug: PlaceboPlacebo tablets q12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF101Also: IB-MECACF101 1 mg tablets orally every 12 hours for 24 weeks | Drug | Drug: CF101 |
| PlaceboAlso: Sugar pillsMatching placebo tablets orally every 12 hours for 24 weeks | Drug | Placebo tablets of CF101 |
Primary outcome
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
1 secondary outcome
Safety of CF101
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CF101 in people with Uveitis, Posterior and Uveitis, Intermediate, run by Can-Fite BioPharma at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of uveitis on standardized photographic assessment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.