Adjunctive Gypenosides for Acute Optic Neuritis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean retinal nerve fibre layer thickness
研究概览
简要总结
This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis.
详细描述
This was a single-center, randomized, double-blind, placebo-controlled pilot trial in adults with a first episode of acute optic neuritis within 28 days of symptom onset. Participants received standard corticosteroid treatment and were randomized in a 1:1 ratio to adjunctive oral gypenosides 180 mg/day for 10 days or matching placebo.
The trial was designed as a pilot study to estimate structural treatment effects and variability for future neuroprotection trials in optic neuritis. The primary structural outcome was peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6 measured by spectral-domain OCT. Secondary outcomes included total macular volume, best-corrected visual acuity, visual evoked potentials, visual-field measures, and safety outcomes.
Macular ganglion cell-inner plexiform layer thickness was analyzed as an exploratory segmentation-derived macular structural endpoint.
Baseline aquaporin 4 immunoglobulin G serostatus was assessed. Myelin oligodendrocyte glycoprotein immunoglobulin G testing was not included in the original study design.
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
Participants, treating clinicians, outcome assessors, and statisticians were masked to treatment assignment. Gypenosides and placebo capsules were prepared and packaged to maintain identical appearance and labeling.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Chinese patients aged ≥18 to ≤60 years
- •Patients with a first episode of optic neuritis in the eye of interest
- •First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
- •Best corrected visual acuity in the eye of interest ≤0.8
排除标准
- •Pre-existing multiple sclerosis MS or NMO
- •Refractive media opacity
- •Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters
- •Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
- •Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
- •Existing other retina or optic nerve diseases
- •Pregnant or females who plan to be pregnant during study
研究组 & 干预措施
Gypenosides
Participants received adjunctive oral gypenosides for 10 days in addition to standard corticosteroid treatment.
干预措施: Gypenosides (Drug)
Placebo
Participants received matching placebo capsules for 10 days in addition to standard corticosteroid treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean retinal nerve fibre layer thickness
时间窗: 6 months
次要结局
- Number of participants with Adverse events(Screening until end of study)
- Best corrected visual acuity(6 months)
- Total macular volume(6 months)
- Latency and amplitude of visual evoked potentials(6 months)
- Mean visual field defect(6 months)
研究者
Yi Du
Dr.
First Affiliated Hospital of Guangxi Medical University