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Nicotinamide and Glaucoma

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nicotinamide
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

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

Inclusion criteria for glaucoma patients: Manifest glaucoma (PEXG, HTG, NTG) in one or two eyes, age > 18 years, replicable visual field defects that cannot be explained by any other disease or insult, suspect/anomalous optic nerve head or abnormalities in the retinal nerve fiber layer. Inclusion criteria for age-matched controls: -A normal visual field and optic nerve, age > 18 years. Exclusion criteria for all: Any disease affecting retinal function (such as more than mild macular degeneration or diabetic retinopathy), neurological or other non-glaucomatous conditions that may affect the visual field, inability to perform a perimetric exam, resistance in quitting intake of multivitamins or B-vitamins, allergy to NAM or niacin, previous eye surgery involving the central retina, pregnant or breast-feeding women, fertile women not using reliable contraception, diagnosis of cancer in the last five years (not including treated squamous cell carcinoma), anamnesis of liver-disease or peptic ulcer, not able to speak and understand either Swedish or English.

Sites / Locations

  • Department of Clinical Science, Ophthalmology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy controls

Pseudoexfoliative glaucoma

POAG

NTG

Arm Description

Healthy controls

PEXG

POAG

NTG

Outcomes

Primary Outcome Measures

Plasma level of NAM before and after NAM treatment in all groups
Are NAM levels in plasma lower in patients with glaucoma compared to healthy controls and will a short-term treatment with NAM raise the plasma concentration of NAM?

Secondary Outcome Measures

Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus
Will a short-term treatment with NAM influence the retinal vasculature measured with OCTA?

Full Information

First Posted
October 4, 2021
Last Updated
June 13, 2023
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT05916066
Brief Title
Nicotinamide and Glaucoma
Official Title
Nicotinamide and Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University

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
The investigators will include different subgroups of open-angle glaucoma and healthy controls. The participants will attend two visits with two weeks apart. At each visit the participants will have blood drawn and will undergo OCT examination. In between the two visits, participants will receive a treatment of Nicotinamide 1,5g/day for one week and 3.0g/day for the second week.
Detailed Description
The investigators plan to recruit four groups, each containing 30 subjects: 1) pseudoexfoliative glaucoma, 2) High tension open-angle glaucoma, 3) Normal tension glaucoma 4) Age-matched controls. Those enrolled will undergo two visits including an ophthalmic exam, blood sampling, and at the first visit, distribution of nicotinamide tablets. We plan to recruit participants amongst glaucoma patients already followed at the Eye Clinic at Umeå University Hospital. Furthermore, age-matched controls will be recruited through lists from the population register at Statistics Sweden. Before enrolling any subject, they will receive both oral and written information as well as sign a consent form. Furthermore, they will be evaluated to make sure that they fulfill the inclusion- and exclusion criteria prior to inclusion. The ophthalmic exam includes measurement of IOP, perimetry, and OCT/A. Between visits, the participants will receive 1,5 grams of NAM per day the first week and 3 grams per day the second week. The blood drawn will initially be sent to Biobanken Norr for storage. Samples will then be sent to the Swedish Metabolomics Centre, Umeå University and Department of Medical Biochemistry and Biophysics, Karolinska University for analysis using high-resolution mass spectrometry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Other
Arm Description
Healthy controls
Arm Title
Pseudoexfoliative glaucoma
Arm Type
Other
Arm Description
PEXG
Arm Title
POAG
Arm Type
Other
Arm Description
POAG
Arm Title
NTG
Arm Type
Other
Arm Description
NTG
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide
Intervention Description
Tabletts of 500mg Nicotinamide (B3-vitamin)
Primary Outcome Measure Information:
Title
Plasma level of NAM before and after NAM treatment in all groups
Description
Are NAM levels in plasma lower in patients with glaucoma compared to healthy controls and will a short-term treatment with NAM raise the plasma concentration of NAM?
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus
Description
Will a short-term treatment with NAM influence the retinal vasculature measured with OCTA?
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for glaucoma patients: Manifest glaucoma (PEXG, HTG, NTG) in one or two eyes, age > 18 years, replicable visual field defects that cannot be explained by any other disease or insult, suspect/anomalous optic nerve head or abnormalities in the retinal nerve fiber layer. Inclusion criteria for age-matched controls: -A normal visual field and optic nerve, age > 18 years. Exclusion criteria for all: Any disease affecting retinal function (such as more than mild macular degeneration or diabetic retinopathy), neurological or other non-glaucomatous conditions that may affect the visual field, inability to perform a perimetric exam, resistance in quitting intake of multivitamins or B-vitamins, allergy to NAM or niacin, previous eye surgery involving the central retina, pregnant or breast-feeding women, fertile women not using reliable contraception, diagnosis of cancer in the last five years (not including treated squamous cell carcinoma), anamnesis of liver-disease or peptic ulcer, not able to speak and understand either Swedish or English.
Facility Information:
Facility Name
Department of Clinical Science, Ophthalmology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90187
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Nicotinamide and Glaucoma

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