The effect of Tetrahydrocannabinol on ocular hemodynamics in patients with primary open angle glaucoma- A Phase II Study

Phase 1

• Conditions: The study will be carried out in patients with primary open angle glaucoma; MedDRA version: 20.0Level: LLTClassification code 10036719Term: Primary open angle glaucomaSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2019-003089-42-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-25
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP = 21 mmHg on at least three measurements in the medical history.
•Mean deviation in the visual field test < 10dB
•Informed consent signed and dated
•Patient aged = 18 years old
•Ametropia = 6 diopters
•Normal findings in the medical history and physical examination including ECG unless the investigator considers an abnormality to be clinically irrelevant
•Normal findings in the laboratory testing unless the investigator considers an abnormality to be clinically irrelevant
•Nonsmokers

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Exfoliation glaucoma
•Pigmentary glaucoma
•Secondary glaucoma
•History of acute angle closure
•Intraocular surgery within the last 6 months
•Filtration surgery for glaucoma at any time
•Laser procedure for glaucoma within the last 12 months
•Visual field not performed or not available within 6 months
•Ocular inflammation or infection within the last 3 months
•Regular use of medication that potentially could interact with THC, abuse of alcoholic beverages or drugs
•History of drug or alcohol abuse
•Psychiatric disorders in the medical history
•Risk for drug dependence as evaluated by a psychiatrist
•Participation in a clinical trial in the 3 weeks preceding the study
•Positive urine drug test at the screening examination or on the study days
•Positive alcohol breath test at the screening examination or on the study days
•Regular consumption of cannabis and inability to not consume cannabis during the study period
•Symptoms of a clinically relevant illness in the 3 weeks before the first study day
•History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
•Blood donation during the previous 3 weeks
•Known hypersensitivity to any of the components of the IMP under investigation or other study medication
•History or family history of epilepsy
•Pregnant or breast-feeding women
•Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and its regulation in patients with primary open angle glaucoma.;Secondary Objective: •Flicker induced increase in retinal blood flow<br>•Retinal vessel diameters<br>•Retinal blood velocities<br>•Retinal oxygen saturation<br>•Retinal vessel density <br>•THC plasma concentration<br>•Normalized blur (LSFG)<br>• Relative flow volume (LSFG);Primary end point(s): Optic nerve head blood flow;Timepoint(s) of evaluation of this end point: Since this is a cross-over study, optic nerve head blood flow will be<br>assessed on both study days before and after administration of<br>dronabinol or placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Flicker induced increase in retinal blood flow<br>•Retinal vessel diameters<br>•Retinal blood velocities<br>•Retinal oxygen saturation<br>•Retinal vessel density <br>•THC plasma concentration<br>•Normalized blur (LSFG)<br>• Relative flow volume (LSFG);Timepoint(s) of evaluation of this end point: Since this is a cross-over study, optic nerve head blood flow will be<br>assessed on both study days before and after administration of<br>dronabinol or placebo.