CTIS2022-502273-42-00招募中1 期
A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eyedrops 2% on visual field preservation in patients with open angle glaucoma - OMK1P3
Omikron Italia S.r.l.0 个研究点目标入组 1,000 人开始时间: 2023年3月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Signed written informed consent. 2.Age = 18 years. 3.Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included. 4.Best Corrected Visual Acuity (BCVA) = 0.5 for the study eye. 5.Controlled IOP (= 18 mmHg, average of the last 3 measurements in the clinic) in the study eye. 6.Visual field MD not worse than -12 dB at the latest assessment in the clinic for the study eye. 7.Glaucoma definition will be based on VF damage (24-2, any SITA strategy) and spatially congruent glaucomatous changes at the ONH. If both eyes are eligible, the eye with the better MD will be chosen as the study eye. Please refer to the following definitions: • OAG: a reproducible glaucomatous VF defect in at least one eye in reliable VFs (false positive rate =15%) with corresponding glaucomatous damage to the Optic Nerve Head (ONH), with an open angle on gonioscopy and in the absence of a retinal, neurological or adnexal condition that could account for the VF loss. • Glaucomatous damage to the Optic Nerve Head: focal or diffuse loss of neuro-retinal tissue identified by the investigator by means of ophthalmoscopy AND/OR fundus photographs AND/OR Optical Coherence Tomography imaging. • Reproducible glaucomatous VF defect: a Glaucoma Hemifield Test (GHT) outside normal limits AND a cluster of 3 or more locations, 2 of which are depressed on the pattern deviation plot at a P value of <5% and 1 of which is depressed at a P value of <1%, on at least 2 consecutive reliable fields. At least 1 common location in the cluster should be depressed at <5% in the 2 consecutive VFs. • Definition of a VF cluster: each depressed location in the clusters should be adjacent to at least one other depressed location. 8.Women of childbearing potential (WOCBP) willing to use a highly effective method of contraception for up to 90 days after the last dose of treatment.
排除标准
- •1.Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years. 2.Only-eye patients (visual acuity < 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of < 10 dB). 3.Known intolerance or allergy to any of the components in the eye drops. 4.Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye. 5.Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG. 6.Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test. 7.Patients already on topical or systemic citicoline treatment. 8.Patients taking other systemic or topical potential neuroprotectors used in glaucoma, i.e., citicoline (CDP-choline), choline and derivatives, coenzyme Q10, vitamin B3 / niacin/ nicotinamide/ nicotinamide riboside chloride /nicotinic acid, ginkgo biloba, and unwilling to suspend these treatments and undergo a washout period of 6 months prior to the study 9.Patients unable to perform reliable VF tests, based on the assessment of the last 4 available 24-2 Humphrey Field Analyzer (HFA) VF tests performed in the clinic with a false positive rate (FP) = 15%. 10.Although effects on the human fetus are considered unlikely, these effects are still unknow and the safety of citicoline for use during pregnancy has not been established. Therefore, pregnant and nursing women will be excluded from the study.
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