Nicotinamide and Glaucoma
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Västerbotten
-
Umeå, Västerbotten, Sweden, 90187
- Department of Clinical Science, Ophthalmology, Umeå University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy controls
|
Tabletts of 500mg Nicotinamide (B3-vitamin)
|
|
Other: Pseudoexfoliative glaucoma
PEXG
|
Tabletts of 500mg Nicotinamide (B3-vitamin)
|
|
Other: POAG
|
Tabletts of 500mg Nicotinamide (B3-vitamin)
|
|
Other: NTG
|
Tabletts of 500mg Nicotinamide (B3-vitamin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma level of NAM before and after NAM treatment in all groups
Time Frame: Two weeks
|
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?
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus
Time Frame: Two weeks
|
Will a short-term treatment with NAM influence the retinal vasculature measured with OCTA?
|
Two weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- NAMG2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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