The Glaucoma Nicotinamide Trial - A Prospective, Randomized, Placebo-controlled, Double-masked Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Visual field progression
研究概览
简要总结
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.
详细描述
The treatment arms that included patients will be randomized into are either Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards or true placebo tablets. A major difference between the SGNT and VBIGS is that in SGNT untreated newly diagnosed glaucoma patients will be included whereas in VBIGS glaucoma patients with intraocular pressure lowering treatment will be included. Also, in SGNT an additional non-blinded arm with healthy subjects will receive Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards. For participants where both eyes are eligible, both will be included.
The primary endpoint is visual field progression change over two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both patients, care givers and investigators are masked to the treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
- •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.
研究组 & 干预措施
Placebo
Participants will receive 750mg placebo tablets 1+1 per day for 6 weeks and after that 2+2 per day.
干预措施: Placebo (Other)
Nicotinamide
Participants will receive 750mg nicotinamide tablets 1+1 per day (1.5g) for 6 weeks and after that 2+2 per day (3.0g).
干预措施: Nicotinamide (Dietary Supplement)
结局指标
主要结局
Visual field progression
时间窗: Two years
Change in rate of progression between the two study arms
次要结局
未报告次要终点