- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596826
The Effect of Dronabinol on Ocular Hemodynamics in Patients With Primary Open Angle Glaucoma
The Effect of Dronabinol on Ocular Hemodynamics in Patients With Primary
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Vienna, Austria, 1090
- Recruiting
- Department of Clinical Pharmacology, Medical University Vienna
-
Contact:
- Doreen Schmidl, MD
- Phone Number: 2988 + 43 1 40400
- Email: doreen.schmidl@meduniwien.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: healthy subjects
|
oral administration
oral administration
oral administration
|
Experimental: glaucoma patients
|
oral administration
oral administration
oral administration
|
Placebo Comparator: healthy volunteers
|
oral administration
oral administration
oral administration
|
Placebo Comparator: Glaucoma patients
|
oral administration
oral administration
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optic nerve head blood flow
Time Frame: 60 minutes on the study day
|
To determine the total blood flow in the eye, OCT measurements were performed with a rectangular scanning pattern around the optical nerve head.
|
60 minutes on the study day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flicker induced increase in retinal blood flow using a Fourier Domain Doppler OCT
Time Frame: 30 minutes on the study day
|
30 minutes on the study day
|
|
Retinal vessel diameter (DVA)
Time Frame: 30 minutes on the study day
|
The DVA allows for the real time measurement of retinal vessel diameters in vivo. The DVA is a commercially available system (IMEDOS, Jena, Germany) which comprises a fundus camera, a video camera, a real time monitor and a personal computer with an analyzing software for the accurate determination of retinal arterial and venous diameters. Every second a maximum of 25 readings of vessel diameter can be obtained. For this purpose the fundus is imaged onto the charge coupled device chip of the video camera. The consecutive fundus images are digitized using a frame grabber. In addition, the fundus image can be inspected on the real time monitor and, if necessary, stored on a video recorder. Evaluation of the retinal vessel diameters can either be done online or offline from the recorded video tapes |
30 minutes on the study day
|
Retinal oxygen saturation (DVA)
Time Frame: 30 minutes on the study day
|
In particular, retinal oxygen saturation measurement is based on the image analysis by the DVA software of two monochromatic fundus images as recorded by a standard DVA.
In an image, obtained by the camera and filter assembly, the operator has to mark the vessel of interest by a mouse click.
The vessel is traced automatically applying the following procedure.
The vessel walls are located as photometric edges in the vicinity of the mouse cursor in the green channel image.
If edges are determined, the search is continued in their proximity.
|
30 minutes on the study day
|
Retinal blood velocities
Time Frame: 15 minutes on the study day
|
We observe bi-directional blood flow and pulsatility of blood velocity in retinal vessels with a Doppler detection bandwidth of 12.5 kHz and a longitudinal velocity sensitivity in tissue of 200μm/s.
|
15 minutes on the study day
|
THC plasma concentration
Time Frame: 120 minutes on the study day
|
Measurements of ocular hemodynamics will be started one hour after administration, since maximum plasma levels are reached 60-120 minutes after administration.
|
120 minutes on the study day
|
Retinal vessel density (OCTA)
Time Frame: 30 minutes on the study day
|
30 minutes on the study day
|
|
Normalized blur (LSFG)
Time Frame: 15 minutes on the study day
|
15 minutes on the study day
|
|
Relative flow volume (LSFG)
Time Frame: 30 minutes on the study day
|
30 minutes on the study day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- OPHT-250719
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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