Nicotinamide treatment for glaucoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Glaucoma Nicotinamide Trial is a randomized, placebo-controlled clinical trial investigating the effects of Nicotinamide on patients with open-angle glaucoma. Participants will be assigned to receive either Nicotinamide or a placebo, with the study including two cohorts: newly diagnosed patients and those already receiving intraocular pressure treatment. The primary goal is to assess changes in visual field progression over a two-year period. The trial aims to provide insights into the neuroprotective effects of Nicotinamide in glaucoma management.

Why it matters

Who can join: the full rules

SGNT:

Inclusion Criteria:

* Adult participants (\>18 years) with newly-diagnosed and previously untreated POAG or PEXG in one or both eyes. Glaucoma is defined as reproducible visual field (VF) defects that cannot be explained by other disease or damage, and a suspect/abnormal optic nerve head and/or nerve fibre layer defect.
* 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

Exclusion Criteria:

* 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),
* IOP \>35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs,
* pregnancy/breastfeeding,
* those unwilling to abstain from NAM supplements,
* 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, •inability to understand and speak Swedish or English,
* a history of intraocular surgery (apart from uncomplicated cataract surgery) and
* diseases that are known to affect retinal function (e.g. \> mild age-related macular degeneration, \> stage I diabetic retinopathy).

VBIGS:

Inclusion Criteria:

* Patients aged 18 years or older, with definitive, treated POAG including normal tension glaucoma, PEXG in both eyes
* Best-corrected visual acuity ≥ 6/18
* Severity of visual field loss, MD between -3 and -18 dB. This range includes people with moderate disease which optimises detection of progression.
* Patient must have performed at least two reliable VFs (24-2), with \<33% fixation losses and \<15% false positives.
* Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if 3 or more months prior, and normal liver function tests.
* Those taking NAM already will undergo a 1-month washout period before commencing the study.

Exclusion Criteria:

* Patients with a history of hepatic disease, gout, visually significant cataracts, other conditions that can affect VF results, cataract surgery in the last 3 months or glaucoma filtration surgery in last 6 months.

Where it's running

• S:t Eriks Eye Hospital
  Stockholm, Sweden Recruiting
• Umeå University
  Umeå, Sweden Recruiting

Study contacts

• Study coordinator: Gauti Jóhannesson
• Email: gauti.johannesson@umu.se
• Phone: +46907850000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.