Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy NSR Device Study - A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Octopus vfiii4e (Progressive slowing of Visual Field deterioration)
研究概览
简要总结
Several studies have shown that TES in RP patients may help to slow the progressive deterioration of this degenerative disease. The end point of this clinical trial is to slow or stop disease progression with weekly treatment using TES for 1 year.
详细描述
The following proposed study (ICM1TES/RP) will investigate the therapeutic aspects of transcorneal electrical stimulation (TES) on the eye in patients with retinitis pigmentosa (RP). It will utilize the Okuvision TES system, a Wills Eye Hospital-sponsored FDA non-significant risk (NSR) medical device, OkuStim® (CE-marked OkuStim®) for the application of electrical stimulation directly to the eye via a corneal contact electrode.
Study Design - Multi-center, prospective, randomized sham controlled 1:1 Clinical trial.
Study treatments - Patients will be randomized in a 1:1 ratio. Patients in treatment group will have TES at 200% of phosphene threshold for 30 minutes once weekly for 52 weeks in both eyes. Patients in sham group will also wear electrodes on both eyes, but no energy is turned on and both eyes are sham.
Duration of study - anticipated duration is 36 months, 12 months for recruitment, 12 months for treatment and sham groups and followed for 18 months, plus 6 months for analysis.
Inclusion Criteria - Diagnosis of RP, 22-80 years of age, no other ocular disease, able to complete all visits.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Retinitis Pigmentosa.
- •Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
- •LogMAR VA 1.00 or better in both eyes.
- •Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
- •Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.
排除标准
- •Visual field loss as demonstrated by Octopus 900 kinetic perimetry as <10 deg of remaining central visual field using stimulus sizes III4e and V4e.
- •Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
- •Diabetic retinopathy
- •Ocular neovascularisation of any origin
- •After arterial or venous occlusion
- •After retinal detachment or any vitreoretinal surgery with or without implantation.
- •Silicone oil tamponade
- •Dry or exudative age-related macular degeneration
- •Macular edema involving the foveal center as determined by SD-OCT
- •All forms of glaucoma
- •Any form of corneal degeneration that reduces visual acuity
- •Systemic diseases that are difficult to control or manage, which could hinder regular attendance at follow-up examinations
- •Patients in a permanently poor general condition, which could hinder regular attendance at follow-up examinations
- •Patients in whom phosphenes are only inducible at greater than, but not including, 0.8 mA.
- •Forms of mental illness related to the bipolar affective and schizoid-affective disorders, epilepsy, and all forms of dementia
- •Simultaneous participation in another interventional study or history of interventions whose effect may still persist
- •Current pregnancy, or being a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for the study duration, or a woman unwilling to perform a pregnancy test at study entry
- •Any patient can be excluded from the study as determined by the Principal Investigator.
研究组 & 干预措施
Treatment group
Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks
干预措施: Transcorneal Electrical Stimulation using Okustim device (Device)
Sham group
Subjects in the Sham group will wear the OkuSpex and OkuEl (applied to cornea upon the lower lid) and be attached to the OkuStim device in the same manner as the treatment group, but will receive no electrical stimulation for the 30 minutes that the TES fiber is applied to the cornea (even though the device has been turned on) once a week for fifty-two weeks
干预措施: Transcorneal Electrical Stimulation using Okustim device (Device)
结局指标
主要结局
Octopus vfiii4e (Progressive slowing of Visual Field deterioration)
时间窗: 76 weeks
Octopus vfiii4e test will be done at Screening visit, Baseline visit, Week 26, Week 53 and Week 76 to analyze progressive slowing of Visual Field deterioration
次要结局
- Visual acuity (VA)(76 weeks)
- Photopic b-wave ERG(76 weeks)
- Contrast sensitivity(76 weeks)
- NEI-VFQ-25 total score & subscores(53 weeks)