Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and
moderate to severe visual loss without substantial recent treatment who are randomly assigned
to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The
primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time
of treatment failure of the eligible eye(s), followed by a continuation study to assess time
to treatment failure. The determination of eligible eye(s) is based on meeting the
eligibility criteria at baseline.
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
Icahn School of Medicine at Mount Sinai National Eye Institute (NEI) University of Iowa