Investigating the Neuroprotective Effect of Cop-1 in Acute Primary Angle Closure
试验速览
- 阶段
- 3 期
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Visual field progression using point-wise linear regression.
研究概览
简要总结
This is a randomised controlled trial to assess the neuroprotective effect of Cop-1 (Copaxone) in patients with acute primary angle closure (APAC). The standardized management of APAC will include medical therapy to reduce intraocular pressure (IOP), followed by laser peripheral iridotomy. Cop-1 will be administered in addition to standard therapy as a subcutaneous dose once within 24 hours of presentation, and then one week later (total 2 injections). The control group will have placebo in addition to standard regimen. Subjects in the study will have visual field test performed with the Humphrey Visual Field Analyzer II, retinal nerve fibre layer (RNFL) thickness measured with the Stratus optical coherence tomography (OCT) and Optic nerve head evaluated with the Heidelberg retinal tomography (HRT). At least 2 baseline visual field tests will also be performed in the first week. Subsequent visits will be at week 4, 8, 12 and 16. The outcome criteria will be difference in visual field, RNFL thickness, and optic nerve head structural changes.
详细描述
Aim To assess the neuroprotective effect of Cop-1 (Copaxone) in reducing functional and structural damage after acute primary angle closure (APAC)
Outcome measures:
The primary outcome measures will be the point-wise linear regression in the visual fields.
The secondary outcome measure will be the evaluation of structural changes, namely, RNFL thickness and Optic disc changes as measured by stratus OCT and HRT respectively.
Study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• patients with APAC who present to the centre not later than 7 days from the initiation of the attack.
- •the presence of at least two of the following symptoms: ocular or periocular pain, nausea or vomiting or both, and an antecedent history of blurring of vision with haloes;
- •a presenting intraocular pressure of at least 28 mm Hg on Goldmann applanation tonometry;
- •the presence of at least three of the following signs: conjunctival injection, corneal epithelial oedema, middilated unreactive pupil, and shallow anterior chamber;
- •the presence of an occludable angle in the affected eye on gonioscopy;
- •Age more than 21 years.
- •Informed consent
排除标准
- •• evidence of a prior acute angle closure attack (the presence of iris whorling, focal iris atrophy, or glaucomflecken with a history of an acute red eye and decreased vision). This will not include senile iris and sphincter atrophy);
- •Pre-existing chronic angle closure glaucoma in the eye with APAC
- •secondary causes of angle closure like subluxed lens, uveitis, trauma and neovascular glaucoma;
- •cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc imaging not technically possible- visual acuity less than 6/36 due to any type of cataract;
- •corneal abnormalities, media opacities, or retinal abnormalities that would affect scanning laser polarimetry;
- •previous intraocular surgery;
- •currently pregnant or nursing women, or women considering pregnancy;
- •Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, respiratory disease, or cancer and life expectancy less than one year.
- •History of allergy to mannitol.
研究组 & 干预措施
Copaxone
COPAXONE (glatiramer acetate) will be administered as a subcutaneous dose (20mg) once, one injection no later than 7 days from the initiation of the attack, and 1 more injection administered one week after the first injection.
干预措施: Copaxone (Drug)
Placebo
Placebo (buffered normal saline w/v)will be administered as a subcutaneous dose, one injection no later than 7 days from the initiation of the attack, and 1 more injection administered one week after the first injection.
干预措施: Placebo (buffered normal saline w/v) (Drug)
结局指标
主要结局
Visual field progression using point-wise linear regression.
时间窗: 16 weeks
次要结局
- The secondary outcome measure will be the evaluation of structural changes of the optic nerve head.(16 weeks)
研究者
Prof Aung Tin
Professor
Singapore Eye Research Institute