Clinical trial NCT05916066: Nicotinamide and Glaucoma
Official title: Nicotinamide and Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Plasma level of NAM before and after NAM treatment in all groups
timeFrame: Two weeks
Secondary outcomes:
measure: Perfusion density and flow index in macula and optic nerve head before and after NAM treatment in all gropus
timeFrame: Two weeks
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Clinical Science, Ophthalmology, Umeå University
state: Västerbotten
Study officials:
References: