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

NCT01033422 | Completed Phase 2 Results

• 1 other identifier: CF101-231GL
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 3

Brief 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 (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.

Conditions

Ocular Hypertension; Glaucoma

Keywords

Glaucoma; Ocular hypertension; Intraocular hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure in mmHg

  The mean of the IOP measurements obtained at week 16

  16 weeks

Secondary Outcomes (1)

• Safety of CF 101

  16 weeks

Study Arms (3)

CF101 1mg

EXPERIMENTAL

CF101 1mg orally q12 hours

Drug: CF101

Placebo

PLACEBO COMPARATOR

matching placebo orally q12 hours

Drug: Placebo for

CF101 2mg

EXPERIMENTAL

CF101 2mg orally q12 hours

Drug: CF101

Interventions

CF101 DRUG

CF101 1 or 2 mg tablets orally every 12 hours for 16 weeks

Also known as: IB-MECA

CF101 1mg; CF101 2mg

Placebo for DRUG

Matching placebo tablets orally every 12 hours for 16 weeks

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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");
• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (3)

Specialized Hospital for Active Treatment for Eye Diseases "Zrenie"

Sofia, 1408, Bulgaria

Location

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

Sofia, 1527, Bulgaria

Location

Bnei Zion Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

CF101; N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine; Sugars

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Zivit Harpaz
• Organization: Can-Fite BioPharma Ltd

zivit@canfite.co.il

972-3-9241114

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: October 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: May 12, 2022
• Results First Posted: May 23, 2019

Record last verified: 2022-05

Locations

BU (2); IL (1)