An Early Phase 1 interventional study of cannabis in Retinitis Pigmentosa, Retinal Degeneration and Cannabis, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Hadassah Medical Organization · Early Phase 1, Interventional, and Basic science
Medical Marijuana is used widely, and its effects on the visual system and the function of the retina have not been investigated thoroughly. Some evidence suggests that cannabinoids may be beneficial in certain degenerative diseases of the retina.
The purpose of the study is
Twenty five healthy subjects and 25 retinitis pigmentosa patients will be recruited and will sign an informed consent form. An initial eye exam will include visual acuity and stereo vision, eye movements and eye movement recording, a full slit lamp eye exam, intra-ocular pressure measurement, visual field, OCT and electrophysiology. The subjects will receive a single sublingual dose of cannabis (THC:CBD 1:1, THC 5 mg, or THE:CBD 1:40, THC 5 mg), and will undergo the above examination again. Subjects will be monitored for 5 hours after the administration of cannabis.
250 studies on the registry are indexed under Retinitis; 28 are open to participants now.
This study's planned enrollment of 50 is above the median of 31 across 158 interventional studies indexed under Retinitis.
Browse Retinitis studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects will undergo a full ocular exam and visual functions will be assessed before and after the administration of a single dose of cannabis (THC:CBD 1:40). On the second study day all subjects will receive a single dose of cannabis (THC:CBD 1:1) and undergo the full ocular exam again.
Drug: cannabis
All subjects will undergo a full ocular exam and visual functions will be assessed before and after the administration of a single dose of cannabis (THC:CBD 1:40). On the second study day all subjects will receive a single dose of cannabis (THC:CBD 1:1) and undergo the full ocular exam again.
Drug: cannabis
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Also known as: cannabidiol, THC
Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response
microvolt
Time frame: 3 hours
Electroretinogram (ERG) - acivity of the neural retina cone flicker latency
milliseconds
Time frame: 3 hours
Visual acuity
LogMAR ETDRS
Time frame: 3 hours
Titmus stereo eye movements
seconds of arc
Time frame: 3 hours
Eye movements
degrees/second
Time frame: 3 hours
Intra ocular pressure
mmHg
Time frame: 3 hours
Macular thickness (OCT)
micrometers
Time frame: 3 hours
Plan to share: No
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization