Randomized Trial of Medical Therapy (MT) vs. MT Plus Optic Nerve Sheath Fenestration (ONSF) vs. MT Plus Ventriculoperitoneal Cerebrospinal Fluid Shunting (VPS) in Subjects With Idiopathic Intracranial Hypertension and Moderate to Severe Visual Loss (SIGHT)

Active Clinical Trials // Jan 28 2019

Sponsor: Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), University of Iowa, Icahn School of Medicine at Mount Sinai
Principal Investigator: Judy Chen, MD
Study Coordinator: Angie Adler

Study Objective:

The primary outcome is visual field mean deviation change at the first of 6 months (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure.

Study Design:

Eligible individuals will be randomly assigned with equal allocation to one of 3 treatment groups: (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. Medical therapy will consist of a low sodium weight loss diet and acetazolamide with or without furosemide. During the randomized trial, follow-up visits will occur at weeks 4, 8, 16, and 26. Safety visits will occur at weeks 1 and 2. Additional office visits may occur as needed. Phone contacts will occur at 12 and 20 weeks. After the 6-month primary outcome visit, subjects will transition to the Treatment Failure Identification Phase for up to 3 years

Diagnosis and Key Eligibility Criteria:

Patients diagnosed with IIH aged 18 to <64 years (at time of consent) with bilateral papilledema with at least one eye meeting all eligibility criteria and no exclusion criteria.

Duration of Study: 3 years

 For more information, contact Angie Adler 608-265-7557.