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NCT07007260Completed

Effect of Niacinamide Supplementation in Glaucoma

Effect of Niacinamide Supplementation in Primary Open-angle Glaucoma

Source: ClinicalTrials.gov · Last updated 17 Jul 2025

Brief summary (registry, in English)

Niacinamide is a chemical derivative of niacin, also known as vitamin B3. Through its complex role in the energetic metabolism, it has been evaluated and proven useful in several neurodegenerative disorders, such as Alzheimer's disease. Its effect in glaucoma, an optic nerve disorder related to a high intraocular pressure, is not well defined, and requires more research. The investigators aim to assess the physiological effects of niacinamide on specific markers (e.g., visual field parameters, retinal nerve fibre layer thickness, electrophysiological markers such as the latency of the P2 wave on Flash visually evoked potentials) and on the quality of life in primary glaucoma patients.

Status (registry)
Completed
Study type
Interventional
Enrollment
58 (actual)
First submitted
13 Jan 2025
Start date
20 Feb 2024
Primary completion date
30 Jun 2025
Lead sponsor
University of Medicine and Pharmacy Craiova
Diseases
Glaucoma
NCT number
NCT07007260

What you commit to

  • Study type: Interventional
  • Participants enrolled: 58
  • From 20 Feb 2024 to the primary completion date, 30 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient is diagnosed with secondary glaucoma (e.g. posttraumatic, post inflammatory, steroid induced, pseudo exfoliative, pigmentary, etc.);
  • Participants who are currently on NAM will be asked to stop taking the tablets for a month prior to screening visit.

Other illness

  • allergic to NAM/niacin,
  • diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma),
  • a history of liver disease or stomach ulcers,
  • disease that prevents long-term follow-up, neurologic or other non-glaucomatous conditions apart from cataract that may affect the VF
  • Patient is diagnosed with other significant ocular pathologies (advanced cataract, pathologic myopia, corneal ectasias or dystrophies, sever amblyopia, vitreoretinal disease, active ocular inflammation, significant sequelae of ocular inflammation);

Other

  • Participants must not be pregnant or breastfeeding women;
  • Investigator considers the subject unfit for the study as a result of medical history, physical examination, or screening tests;
    • •● VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentral spot with -10dB or less in any eye),
  • OP \>35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs,
  • those unwilling to abstain from NAM supplements,
  • Patient is diagnosed with primary angle closure glaucoma;
  • Patient is diagnosed with very advanced glaucoma (foveal fixation threatened or absent and, thus, unreliable perimetry);
  • Unreliable ophthalmological investigations and non-compliance with examinations (e.g. high percentage of false negative and false positive errors when examining the visual field).

Who the study is looking for

  • Patients aged 18 years or older;
  • Confirmed diagnosis of Primary Open angle Glaucoma (POAG) - following a complete ophthalmological examination (ocular tonometry, slit lamp ocular examination, visual field and Optical coherence tomography); Subject has provided signed and dated written informed consent before admission to the study.
  • Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
  • Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better.
  • Have performed at least two reliable VFs (SITA-Fast 24-2), with \<33% fixation losses and \<15% false positives
  • Those taking NAM already will undergo a 1-month washout period before commencing the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Medicine and Pharmacy of Craiova
Coordinator of this site? Confirm its status
CraiovaRomaniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.