Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596826
Status:
RECRUITING
Last Update Posted:
2022-12-15
First Post:
2020-10-14
Brief Title:
The Effect of Dronabinol on Ocular Hemodynamics in Patients With Primary Open Angle Glaucoma
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
The Effect of Dronabinol on Ocular Hemodynamics in Patients With Primary
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glaucoma is among the leading causes for irreversible blindness worldwide While lowering intraocular pressure IOP remains the mainstay of therapy there are still some patients who progress despite well-controlled IOP There is evidence from several studies that ocular blood flow and its regulation is impaired in patients with glaucoma Tetrahydrocannabinol THC has been used in the treatment for glaucoma in some countries for several years due to its IOP lowering effect In addition there is also evidence that THC features neuroprotective effects and improves ocular hemodynamics Dronabinol is a synthetic THC that is legally available in several European countries It has the advantage that exact dosing of THC is possible in contrast to previously applied administration forms such as smoking Due to its legal status in the past data about the effect of THC on ocular blood flow and its regulation are sparse In a recent study conducted in the investigators laboratory they found that single administration of dronabinol leads to a significant increase in optic nerve head ONH blood flow without impairing its autoregulatory capacityThe aim of the present study therefore is to investigate whether single administration of dronabinol alters optic nerve head ONH blood flow in patients with open angle glaucoma In addition other parameters for ocular blood flow will be measured in particular retinal blood flow retinal oxygen saturation and retinal neurovascular coupling The study will be conducted in a parallel-group randomized double-masked placebo-controlled cross-over design Patients will be randomized to either receive 5mg or 10mg dronabinol on one study day Other studies investigating retinal hemodynamics or IOP after administration of THC also have used similar or slightly higher doses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None