NCT06078605招募中不适用
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
研究概览
简要总结
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
- •In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
- •Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
- •Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB)
- •Have performed a reliable visual field in the last year, with <33% fixation losses, false positives and false negatives.
- •Written consent voluntarily to participate in this clinical trial.
排除标准
- •Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- •BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
- •Patients who have medical history of ocular inflammation
- •Patients with any ocular/systemic conditions that may affect electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic retinopathy, Macular degeneration etc.)
- •Patients who have plans to intraocular surgery within the clinical trial period.
- •Patients with a history of significant ocular trauma within 6 months prior to the screening visit
- •Pregnant or lactating women.
- •A person who disagrees to contraception during a clinical trial period.
- •Patients with a history of malignancy within 5 years prior to the screening visit.
- •Patients that other researchers are determined inadequately.
研究组 & 干预措施
Nicotinamide(Mitovita)
Experimental
Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID)
干预措施: Nicotinamide(Mitovita) (Other)
Placebo
Placebo Comparator
Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID)
干预措施: Placebo (Other)
结局指标
主要结局
Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)
时间窗: Baseline,12weeks
Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks
次要结局
- Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)(Baseline, 6, 12, 18, 24weeks)
- Change of visual field sensitivity number of locations(Baseline, 12weeks, 24weeks)
- Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)(Baseline, 6, 12, 18, 24weeks)
- Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)(Baseline, 12weeks, 24weeks)
- Change of mean deviation as measured by Visual Fields (intra-group)(Baseline, 12weeks, 24weeks)
- Change of mean deviation as measured by Visual Fields (Group1 VS Group2)(Baseline, 12weeks, 24weeks)
研究者
研究点 (1)
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