Nicotinamide and Glaucoma

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT05916066

Collaborator

(none)

120

Enrollment

Location

Arms

6.4

Actual Duration (Months)

18.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Dietary Supplement: Nicotinamide	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Nicotinamide and Glaucoma

Actual Study Start Date :

Oct 16, 2021

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy controls Healthy controls	Dietary Supplement: Nicotinamide Tabletts of 500mg Nicotinamide (B3-vitamin)
Other: Pseudoexfoliative glaucoma PEXG	Dietary Supplement: Nicotinamide Tabletts of 500mg Nicotinamide (B3-vitamin)
Other: POAG POAG	Dietary Supplement: Nicotinamide Tabletts of 500mg Nicotinamide (B3-vitamin)
Other: NTG NTG	Dietary Supplement: Nicotinamide Tabletts of 500mg Nicotinamide (B3-vitamin)

Outcome Measures

Primary Outcome Measures

Plasma level of NAM before and after NAM treatment in all groups [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?

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Science, Ophthalmology, Umeå University	Umeå	Västerbotten	Sweden	90187

Sponsors and Collaborators

Umeå University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Umeå University

ClinicalTrials.gov Identifier:

NCT05916066

Other Study ID Numbers:

NAMG2021

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2023