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 range18 Years
SexALL
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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.
✓. Women of child bearing potential must use adequate birth-control precautions.