A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26
研究概览
简要总结
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants, either men or women are ≥ 18 years of age.
- •Diagnosis of ischemic optic neuropathy unilateral or bilateral:
- •Traumatic Neuropathy
- •Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION)
- •Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both.
- •Field of view with a reduction from 10 degrees to one quarter situations functions.
- •Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
- •Women of child bearing potential must use adequate birth-control precautions.
排除标准
- •Neuropathy caused by tumors.
- •Neuropathy caused by infections
- •Mitochondrial optic neuropathies
- •Nutritional, Radiation, Toxic optic neuropathies
- •Retinal diabetic complications
- •Hereditary optic neuropathies
- •Patients with complete SCOTOMA beyond three quarters.
- •Clinical evidence for presence of infection.
- •Patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
- •Patient has a history of alcohol or drug abuse within the last two years.
- •Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- •Participation in another clinical trial within 60 days prior to the Screening Visit or during this study.
- •Clinically significant and/or uncontrolled condition or other significant medical disease
- •Clinically significant uncontrolled retinal disease (AMD)
研究组 & 干预措施
RPh201
3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201
干预措施: RPh201 (Drug)
Placebo
3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26
时间窗: 26 weeks
TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.
Changes in Visual Field Observed Following the Treatment
时间窗: 26 weeks
Visual field mean deviation (MD) changes from the screening at week 26 using with the HVF 24-2 FASTPAC program using the size III or Size V test stimulus
Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit
时间窗: 26/39 weeks
Best Corrected Visual Acuity (BCVA) was assessed at all the visits, with refraction as necessary. VA measurements were taken in a sitting position at a test distance of 4 meters using early treatment diabetic retinopathy study (ETDRS) charts.
次要结局
- Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam(26/39 weeks)