Safety and Efficacy of Daily CF101 in Patients With High Intraocular Pressure
- Conditions
- patients with elevate intraocular pressureMedDRA version: 18.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-002777-27-BG
- Lead Sponsor
- Can-Fite BioPharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
1. Male or female, 18 years of age and over;
2. Ocular hypertension or open-angle glaucoma in at least 1 eye,
diagnosed as any of the following:
a. Untreated ocular hypertension without glaucomatous
anatomic or VF changes; or
b. Glaucoma diagnosed within the past 2 months but
untreated;
c. 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
d. 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”);
3. 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;
4. 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 (see Section 8.2.2);
5. Corneal thickness between 500 and 580 microns in both eyes
(see Section 8.2.2);
6. Corrected visual acuity +0.18 logMAR or better by Early
Treatment Diabetic Retinopathy Study (ETDRS) methodology
in the candidate eye (equivalent to 20/30);
7. Females of child-bearing potential must have a negative blood
pregnancy test at screening and throughout the study, to be
eligible for, and continue participation in, the study;
8. 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;
9. Ability to complete the study in compliance with the protocol;
and
10. Ability to understand and provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. IOP >32 mmHg in either eye;
2. History of angle-closure glaucoma;
3. Anatomically narrow angles in either eye (ie, =75% of the
circumference of the angle must be =Grade 2 by Shaffer
criteria2);
4. 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 (see
Section 8.2.2), defined as either:
a. Mean deviation worse than -16 dB, or
b. 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);
5. 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 (see Appendix 2 in Section 17);
6. Documented disc hemorrhage within the past 5 years in either
eye;
7. Secondary cause of IOP elevation;
8. Glaucoma laser treatment in candidate eye within the past 3
months;
9. Clinically significant ocular trauma to candidate eye within the
past 6 months;
10. 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;
11. Astigmatism >3 diopters in either eye;
12. 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;
13. Concomitant contact lens use;
14. 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;
15. Any abnormality preventing reliable applanation tonometry;
16. Presence of uncontrolled asthma;
17. Presence of uncontrolled arterial hypertension or symptomatic
hypotension;
18. 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;
19. Hemoglobin level <9.0 gm/L at screening;
20. Platelet count <125,000/mm3 at screening;
21. White blood cell count <3500/mm3 at screening;
22. Serum creatinine level greater than 1.5 times the laboratory’s
upper limit of normal (ULN) at screening;
23. Liver aminotransferase levels greater than 2 times the
laboratory’s ULN at screening;
24. Known or suspected immunodeficiency or human
immunodeficiency virus positivity;
25. Known infection with hepatitis B or C;
26. Pregnancy, planned pregnancy, lactation, or inadequate
contraception as judged by the Investigator;
27. Previous receipt of CF101;
28. 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);
29. Active drug or alcohol dependence;
30. Significant acute or chronic medical, ophthalmic, neurologic,
or psychiatric illness that, in the judgment of the Investig
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the effects of oral CF101 in lowering intraocular pressure (IOP) when administered twice daily for 16 weeks in subjects with elevated IOP; and Determine the safety of oral CF101 in this subject population<br>;Secondary Objective: Not applicable;Primary end point(s): Efficacy: Effects on IOP;<br>Safety: AE reporting, physical examination, vital signs, ophthalmologic and slit lamp examination, (VF) assessments, clinical laboratory testing<br>;Timepoint(s) of evaluation of this end point: 2 - 16 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable