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The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients

Primary Purpose

Retinitis Pigmentosa, Retinal Degeneration, Cannabis

Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
cannabis
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa, retinal degeneration, cannabis, THC, CBD, electrophysiology, visual functions, eye, retina

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • consenting adults
  • generally healthy with or without retinitis pigmentosa

Exclusion Criteria:

  • chronic or acute disease other than retinitis pigmentosa
  • use of medication
  • congestive heart failure
  • recent use of illicit drugs (past month)
  • history of drug dependency
  • history of psychiatric disorder in subject or immediate relatives
  • pregnancy

Sites / Locations

  • Hadassah Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

healthy

Retinitis Pigmentosa

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response
microvolt
Electroretinogram (ERG) - acivity of the neural retina cone flicker latency
milliseconds

Secondary Outcome Measures

Visual acuity
LogMAR ETDRS
Titmus stereo eye movements
seconds of arc
Eye movements
degrees/second
Intra ocular pressure
mmHg
Macular thickness (OCT)
micrometers

Full Information

First Posted
February 10, 2017
Last Updated
February 11, 2021
Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT03078309
Brief Title
The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
Official Title
A Controlled Study of the Effect of Cannabis on Visual Functions in Healthy Subjects and in Retinitis Pigmentosa Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 To determine whether cannabis derivatives affect the visual functions in healthy adults To examine the effect of cannabis derivatives on the retina of retinitis pigmentosa patients
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Retinal Degeneration, Cannabis
Keywords
retinitis pigmentosa, retinal degeneration, cannabis, THC, CBD, electrophysiology, visual functions, eye, retina

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Arm 1 - healthy subjects. Arm 2 - subjects with retinitis pigmentosa 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.
Masking
Outcomes Assessor
Masking Description
Electrophysiology will be analyzed by a blinded investigator.
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy
Arm Type
Experimental
Arm Description
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.
Arm Title
Retinitis Pigmentosa
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cannabis
Other Intervention Name(s)
cannabidiol, THC
Intervention Description
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Primary Outcome Measure Information:
Title
Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response
Description
microvolt
Time Frame
3 hours
Title
Electroretinogram (ERG) - acivity of the neural retina cone flicker latency
Description
milliseconds
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Visual acuity
Description
LogMAR ETDRS
Time Frame
3 hours
Title
Titmus stereo eye movements
Description
seconds of arc
Time Frame
3 hours
Title
Eye movements
Description
degrees/second
Time Frame
3 hours
Title
Intra ocular pressure
Description
mmHg
Time Frame
3 hours
Title
Macular thickness (OCT)
Description
micrometers
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: consenting adults generally healthy with or without retinitis pigmentosa Exclusion Criteria: chronic or acute disease other than retinitis pigmentosa use of medication congestive heart failure recent use of illicit drugs (past month) history of drug dependency history of psychiatric disorder in subject or immediate relatives pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Mechoulam, MD
Phone
9293077002
Email
hadasm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadas Mechoulam, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Mechoulam, MD
Phone
972-2-6776397
Email
Hadasm@gmail.com
First Name & Middle Initial & Last Name & Degree
Orly Harari
Phone
972-2-6777159
Email
orlyy@hadassah.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24495949
Citation
Lax P, Esquiva G, Altavilla C, Cuenca N. Neuroprotective effects of the cannabinoid agonist HU210 on retinal degeneration. Exp Eye Res. 2014 Mar;120:175-85. doi: 10.1016/j.exer.2014.01.019. Epub 2014 Feb 1.
Results Reference
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PubMed Identifier
15182912
Citation
Russo EB, Merzouki A, Mesa JM, Frey KA, Bach PJ. Cannabis improves night vision: a case study of dark adaptometry and scotopic sensitivity in kif smokers of the Rif mountains of northern Morocco. J Ethnopharmacol. 2004 Jul;93(1):99-104. doi: 10.1016/j.jep.2004.03.029.
Results Reference
background
PubMed Identifier
27930772
Citation
Lyons CJ, Robson AG. Retinal Ganglion Cell Dysfunction in Regular Cannabis Users: Is the Evidence Strong Enough to Consider an Association? JAMA Ophthalmol. 2017 Jan 1;135(1):60-61. doi: 10.1001/jamaophthalmol.2016.4780. No abstract available.
Results Reference
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The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients

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