Nicotinamide treatment for glaucoma patients
The Glaucoma Nicotinamide Trial - A Prospective, Randomized, Placebo-controlled, Double-masked Trial
This study is testing if Nicotinamide can help people with open-angle glaucoma keep their vision from getting worse over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Trial ID | NCT05275738 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with newly diagnosed and untreated primary open-angle glaucoma or pseudoexfoliation glaucoma.
Not a fit: Patients with severe visual field damage or those with high intraocular pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could offer a new neuroprotective treatment option for patients with glaucoma, potentially slowing disease progression.
How similar studies have performed: While the approach of using Nicotinamide for glaucoma is novel, previous studies have shown promise in neuroprotection for other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stockholm and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.