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New treatment option for Glaucoma
Official title The Glaucoma Nicotinamide Trial
ClinicalTrials.gov ID: NCT05275738
What this study is testing
- What it's testing
- The Glaucoma Nicotinamide Trial (TGNT) is a prospective, randomized, placebo-controlled double-masked clinical trial composed of two cohorts; The Swedish Glaucoma Nicotinamide Trial (SGNT) and the Vitamin B3 In Glaucoma Study (VBIGS). Patients with open-angle glaucoma (OAG) will be randomized to receive either Nicotinamide or placebo through block randomization stratified by glaucoma subtype with a 1:1 allocation.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- SGNT:
- Adult participants (\>18 years) with newly-diagnosed and previously untreated POAG or PEXG in one or both eyes. Glaucoma is defined as reproducible...
- 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
You likely can't join if
- 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),
See the full eligibility criteria
- SGNT:
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
- Umeå, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden; Umeå, Sweden. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.