NCT00355095已完成2 期
Double Blind, Placebo-controlled Study to Determine the Safety and Efficacy of Erythropoietin as an add-on Therapy of Methylprednisolone in Subjects With Acute Optic Neuritis (VISION PROTECT)
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.
详细描述
SUMMARY This study is a multicenter, double-blind, placebo-controlled, parallel-group study to determine the safety and efficacy of erythropoietin (Epo) as an add-on therapy to methylprednisolone (Mpred) in subjects with acute autoimmune optic neuritis.
The primary study endpoint is nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4, 8, and 16 compared to baseline.
Further study objectives include visual acuity, visual field perception, optic nerve atrophy determined by magnetic resonance imaging (MRI), and recovery of visual evoked potentials (VEPs).
A number of 40 subjects will be randomized in equal numbers into one of the two treatment groups.
Treatment groups:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization:
- •Must give written informed consent and authorize the release and use of protected health information (PHI).
- •Must be 18 to 50 years old, inclusive, at the time of informed consent.
- •Must have acute unilateral optic neuritis with or without prior diagnosis of MS (according to McDonald criteria).
- •Symptoms related to optic neuritis must exist for no longer than 10 days prior to inclusion.
- •Must have had normal visual acuity on both eyes before and no history of optic neuritis.
- •Must have a decreased visual acuity on the affected eye to 0.5 or less at screening.
排除标准
- •Candidates will be excluded from study if any of the following exclusion criteria exist at the time of randomization:
- •Medical history:
- •Abnormal laboratory results or clinical signs indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease.
- •History of prior optic neuritis on the affected or non-affected eye.
- •History of squint or amblyopia on either side.
- •Hyperopia > 3dptr on either side.
- •Myopia < -5dptr on either side.
- •Astigmatism > 2dptr on either side.
- •Horizontal cup disc ratio > 0.5 on either side.
- •Retinal nerve fiber layer thickness outside normal values (with respect to the OCT data base).
- •Ocular diseases effecting visual acuity or visual fields (cataract, glaucoma, maculadegeneration, diabetic retinopathy, retinal heredodegeneration or others).
- •History of elevated blood pressure.
- •Systolic blood pressure of > 159 mmHg, diastolic blood pressure > 99 mmHg at screening examination.
- •History of thromboembolic events.
- •Frequent thromboembolic events in 1st grade family members.
- •Significant surgery within the 4 weeks prior to randomization.
- •History of severe allergic or anaphylactic reactions after administration of Epo.
- •History of malignancy.
- •History of seizures.
- •Tuberculosis with ongoing or unknown activity.
- •Acute gastrointestinal ulceration within the last three months.
- •Acute virus, bacterial or fungus infection.
- •Infection with HIV, HBV, or HCV.
- •History of colitis ulcerosa, diverticulitis, or acute enteroanastomosis.
- •Severe osteoporosis.
- •Active immunization within 2 weeks prior to inclusion.
- •Diagnosis of phenylketonuria.
- •Implanted cardiac pacemaker or other non MRI-compatible metallic body implants.
- •History of drug or alcohol abuse (as defined by the investigator) within 2 years prior to randomization.
- •Any of the following abnormal blood tests at screening: alanine transaminase/serum glutamate-pyruvate transaminase (AST/SGPT), or aspartate transaminase/serum glutamicoxaloacetic transaminase (AST/SGOT), gamma-glutamyl-transferase (GGT), or serum creatinine > 2 times the upper limit of normal; hematocrit > the upper limit of normal.
- •Treatment history
- •Prior treatment with cyclosporine, mitoxantrone, methotrexate, cyclophosphamide or other immunosuppressive agents.
- •Treatment with corticosteroids or Epo within 30 days prior to randomization. Miscellaneous
- •Female subjects considering becoming pregnant while in the study.
- •Female subjects who are currently pregnant or breast-feeding.
- •Previous participation in this study or any other investigational drug study within the last four weeks.
- •Current enrollment in any other investigational drug study.
- •Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- •Any other reasons that, in the opinion of the investigator, the subject is determined to be unsuitable for enrollment in this study.
研究组 & 干预措施
1
Active Comparator
erythropoietin
干预措施: Erythropoietin (Drug)
结局指标
主要结局
nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.
时间窗: 4 months
次要结局
- Visual acuity and visual field perception determined at weeks 1, 4, 8, 16 compared to baseline (week 0). MRI measurements of optic nerve atrophy performed at weeks 4, 8 and 16 compared to baseline (week 0)(4 months)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
3 期
Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (REVIVAL-3)Angioplasty, Transluminal, Percutaneous CoronaryMyocardial InfarctionNCT00390832Deutsches Herzzentrum Muenchen138
Unknown
2 期
The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple SclerosisMultiple Sclerosis (Primary or Secondary Progressive Phase).NCT01144117Rigshospitalet, Denmark56
Unknown
4 期
Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell TransplantationHematopoietic Stem Cell TransplantationLymphomaAnemiaNCT03010579Peking University70
已完成
2 期
Safety Study of Carbamylated Erythropoietin to Treat Patients With the Neurodegenerative Disorder Friedreich's AtaxiaFriedreich's AtaxiaNCT01016366H. Lundbeck A/S36
已完成
4 期
PROTECT: Prospective Trial on Erythropoietin in Clinical TransplantationPatients Receiving a Kidney From a Non-Heart-Beating DonorNCT00157300Leiden University Medical Center92