AzTrials
AzTrials

Ocular HypertensionPhase 2NCT01033422

Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure

A Phase 2 study testing CF101 in people with Ocular Hypertension and Glaucoma, run by Can-Fite BioPharma at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will test the hypothesis that CF101, administered orally, will reduce intraocular pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators, and will receive either CF101 pills or placebo… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ocular Hypertension, Glaucoma
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
89 participants
Where
3 sitesin 2 countries
Study dates
Oct 2010to Apr 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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;
  • Ocular hypertension or open-angle glaucoma in at least 1 eye, diagnosed as any of the following:
  • Untreated ocular hypertension without glaucomatous anatomic or VF changes; or
  • Glaucoma diagnosed within the past 2 months but untreated;
  • Previously treated glaucoma, provided that previous medication treatment has been inefficacious and/or intolerable, and has therefore been discontinued at least 3 weeks prior to Baseline; or
  • Currently treated glaucoma with inadequate IOP control, meaning that IOP remains above target pressure as judged by the Investigator despite ≥3 weeks of treatment with a standard topical regimen (for guidance, the European Glaucoma Society defines "target pressure" as follows: "In most cases a peak IOP = 8 mm - 15 mmHg on a diurnal curve, or 30% IOP reduction from baseline");
Show all 14Show fewer
  • In subjects receiving a standard topical treatment regimen (per 2.d. above), the regimen and dose have not changed within 3 weeks of Screening, and are expected to remain stable throughout the treatment period;
  • At both Screening and Baseline, IOP in at least 1 eye ("candidate" eye) is >21 mmHg at 0800-1000 hours and >21 mmHg in at least 1 measurement at least 3 hours following the first;
  • Corneal thickness between 500 and 580 microns in both eyes;
  • Corrected visual acuity +0.18 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) methodology in the candidate eye (equivalent to 20/30);
  • Females of child-bearing potential must have a negative urine pregnancy test at screening and throughout the study, to be eligible for, and continue participation in, the study;
  • Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (eg, oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
  • Ability to complete the study in compliance with the protocol; and
  • Ability to understand and provide written informed consent.

Who cannot join

  • IOP >32 mmHg in either eye;
  • History of angle-closure glaucoma;
  • Anatomically narrow angles in either eye (ie, ≥75% of the circumference of the angle must be ≥Grade 2 by Shaffer criteria );
  • In subjects with glaucoma, advanced VF defect in either eye, determined on reliable testing using the Humphrey Full-Threshold Algorithm for the Glaucoma Hemifield Test, defined as either:
  • Mean deviation worse than -16 dB, or
  • Threat to fixation (sensitivity 10 dB or worse affecting either or both test points closest to the point of fixation in the upper hemifield and at either or both the corresponding test points in the lower hemifield);
Show all 34Show fewer
  • In subjects with ocular hypertension, a score of >12 points on The Ocular Hypertension Treatment Study Group and European Glaucoma Prevention Study Group Primary Open-Angle Glaucoma Risk Table;
  • Documented disc hemorrhage within the past 5 years in either eye;
  • Secondary cause of IOP elevation;
  • Glaucoma laser treatment in candidate eye within the past 3 months;
  • Clinically significant ocular trauma to candidate eye within the past 6 months;
  • Any major ocular surgery in the past, including keratorefractive surgery, in candidate eye, except for uncomplicated cataract surgery performed greater than 6 months prior to Screening;
  • Astigmatism >3 diopters in either eye;
  • Clinically significant acute or chronic ocular disease (eg, corneal edema, uveitis, severe keratoconjunctivitis sicca, active ocular infection, active herpes simplex keratitis, blepharitis, or acute conjunctivitis) that might interfere with the study;
  • Concomitant contact lens use;
  • Concomitant use of systemic medication that may affect IOP (eg, beta blockers, corticosteroids, calcium channel blockers, ACE inhibitors, or carbonic anhydrase inhibitors); however, systemic antihypertensive medications are allowed providing that the dose and regimen have been stable for at least 3 months prior to Screening and are expected to remain stable throughout the trial;
  • Any abnormality preventing reliable applanation tonometry;
  • Presence of uncontrolled asthma;
  • Presence of uncontrolled arterial hypertension or symptomatic hypotension;
  • Significant cardiac arrhythmia or conduction block, congestive heart failure (New York Heart Association Class 3-4), or any other evidence of clinically significant heart disease or clinically significant findings on screening ECG;
  • Hemoglobin level <9.0 gm/L, at screening;
  • Platelet count <125,000/mm3, at screening;
  • White blood cell count <3500/mm3, at screening;
  • Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal (ULN), at screening;
  • Liver aminotransferase levels greater than 2 times the laboratory's ULN, at screening;
  • Known or suspected immunodeficiency or human immunodeficiency virus positivity;
  • Known infection with hepatitis B or C;
  • Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
  • Previous receipt of CF101;
  • History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin and ≤3 cutaneous squamous cell carcinomas, all of which have been completely excised);
  • Active drug or alcohol dependence;
  • Significant acute or chronic medical, ophthalmic, neurologic, or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study;
  • Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
  • Other conditions which would confound the study evaluations or endanger the safety of the subject.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Bulgaria2 sites

  • Specialized Hospital for Active Treatment for Eye Diseases "Zrenie"

    Sofia, 1408

  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"

    Sofia, 1527

Other trials in Bulgaria

Israel1 site

  • Bnei Zion Medical Center

    Haifa

Other trials in Israel

About this study

Official title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure

This study will test the hypothesis that CF101, administered orally, will reduce intraocular pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators, and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a regular basis.

Read the detailed description

This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of glaucoma or ocular hypertension.

This trial will be performed in 2 segments. In Segment 1, subjects will be randomized to receive either CF101 1.0 mg, or matching placebo, given orally every 12 hours for 16 weeks. Segment 1 will enroll approximately 44 subjects, randomized in a 3:1 ratio to CF101 1.0 mg or to placebo. At the conclusion of Segment 1, a Data Review Committee (DRC) will review safety and efficacy data and advise on progression of the trial to Segment 2. Segment 2 will enroll up to approximately 44 subjects randomized in a 3:1 ratio to CF101 2.0 mg 3:1 ratio to receive with CF101 2.0 mg, or matching placebo, given orally every 12 hours for 16 weeks.

At a Screening Visit (Visit 1, performed within 4 weeks prior to Baseline), subjects who provide written informed consent will have screening procedures performed, including complete medical, ophthalmologic, and medication histories; physical examination; vital signs and weight; electrocardiogram (ECG); ophthalmologic examination; tonometry; visual field (VF) assessment; corneal pachymetry; evaluation of inclusion and exclusion criteria; safety laboratory tests; serum pregnancy test for all females of child-bearing potential; and collection of concomitant medication information.

Subjects who successfully qualify will be randomized at Baseline (Visit 2) to their assigned medication (CF101 or matching placebo) to be taken orally every 12 hours for 16 weeks. Subjects will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, and for final assessment and discharge at Week 16. A safety telephone call will be made at Week 18.

Being tested
CF101, Placebo for
Keywords
Glaucoma, Ocular hypertension, Intraocular hypertension
Medical subject headings
Ocular Hypertension, Glaucoma

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 or 2 mg tablets orally every 12 hours for 16 weeks

  • Placebo forDrug

    Also called Sugar pill

    Matching placebo tablets orally every 12 hours for 16 weeks

Study groups in NCT01033422
Study groupRoleWhat they receive
CF101 1mgExperimentalCF101 1mg orally q12 hours
Receives: Drug: CF101
PlaceboPlacebo comparatormatching placebo orally q12 hours
Receives: Drug: Placebo for
CF101 2mgExperimentalCF101 2mg orally q12 hours
Receives: Drug: CF101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraocular Pressure in mmHg

    The mean of the IOP measurements obtained at week 16

    Measured: 16 weeks

Secondary outcomes (1)

  1. Safety of CF 101

    To tabulate and enter the frequency (number) of adverse events during the treatment period of CF 101, by treatment arm.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2009 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2016
  4. Study completionApr 2017

Resources

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
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01033422
Sponsor's protocol ID
CF101-231GL
Status last verified
May 2022
First submitted
15 Dec 2009
Last updated
12 May 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CF101 in people with Ocular Hypertension and Glaucoma, run by Can-Fite BioPharma at 3 sites in 2 countries.

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 14 inclusion and 34 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: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Bulgaria, 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?

Yes. Results are posted in the registry (first posted 23 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intraocular Pressure in mmHg (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01033422.

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 12 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in