Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION). (NCT02045212) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Israel22 participantsStarted 2014-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit
Timeframe: 26/39 weeks
2
Changes in Visual Field Observed Following the Treatment
Timeframe: 26 weeks
3
Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26