NCT00856635已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Retinal Nerve Fiber Layer Thickness at Baseline and Month 6
研究概览
简要总结
The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 45 years
- •Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.
- •Able to provide written informed consent prior to enrollment
- •Willing and able to comply with the protocol requirements for the duration of the study
- •For women of child bearing potential:
- •A negative urine pregnancy test o
- •Willing to practice an acceptable method of birth control •
- •Willing to receive a steroidal regimen
排除标准
- •A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)
- •Current use of any approved disease modifying agents for treatment of MS
- •Prior clinical episode of optic neuritis in either eye
- •Bilateral AON
- •Inability to undergo study evaluations in both eyes
- •Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
- •Retrogeniculate visual loss
- •Refractive error of greater than +6 or -6 diopters
- •Neuromyelitis Optica (Devic's disease)
- •Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
- •Known ocular conditions that preclude dilation
- •Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
- •Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
- •Diabetes Mellitus Types I or II
- •Gastric bypass surgery
- •Current use of chemotherapy or radiotherapy
- •Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
- •Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
- •Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures
- •Use of an investigational drug within 30 days prior to randomization
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo subcutaneous injection once a day for up to 6 months.
干预措施: placebo (Drug)
Glatiramer acetate
Experimental
Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
干预措施: Glatiramer Acetate (Drug)
结局指标
主要结局
Retinal Nerve Fiber Layer Thickness at Baseline and Month 6
时间窗: Baseline and Month 6
Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.
次要结局
- To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.(6 months)
研究者
相似试验
Unknown
1 期
An Open Label, Exploratory Study to Investigate the Treatment Effect of Glatiramer Acetate on Girls Woth Rett SyndromeRett SyndromeNCT02023424Sheba Medical Center10
终止
3 期
Randomized Trial of Glutamine in Patients With Mucositis or EsophagitisAdvanced CancersNCT01952847M.D. Anderson Cancer Center77
已完成
3 期
Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated SyndromeMultiple SclerosisNCT00666224Teva Branded Pharmaceutical Products R&D, Inc.481
尚未招募
不适用
Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 DiabetesEfficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM PatientsMetformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect128 Patients Were Randomly Assigned 1:1Metformin and Insulin Glargine Combined With Chiglitazar Sodium Tablets 48mg/ Day GroupMetformin and Insulin Glargine Combined With Placebo GroupInvestigatorInitiate TrialChanges in HbA1C From Baseline at 18 Weeks of TreatmentNCT06007014Yanbing Li128
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive ImpairmentAlzheimer DiseaseDementiaNCT00236574Johnson & Johnson Pharmaceutical Research & Development, L.L.C.974