A Trial to Determine the Efficacy and Safety of Presendin in IIH

Exclusion criteria

• ✕. Presence of venous sinus thrombosis on brain imaging by either magnetic resonance or computerised tomographic venography.
• ✕. Previous IIH surgery including CSF shunt, optic nerve sheath fenestration or dural venous sinus stent or sub-temporal decompression.
• ✕. Previous bariatric surgery within the last 3 months or intention during the trial.
• ✕. Abnormal neurological examination (aside from papilloedema and consequent visual loss or sixth or seventh nerve palsy or palsies).
• ✕. Treatment to lower ICP within 1 week prior to screening visit (e.g., acetazolamide, topiramate \[including if used as a migraine preventative\], diuretics, glucocorticoids \[I.V., injectable steroids or oral (including dexamethasone and prednisolone)\]). Nasal, inhaled, or topical steroids are allowed.
• ✕. Use of any drugs known to cause intracranial hypertension, including exposure to fluoroquinolones, lithium, vitamin A, or tetracyclines within 2 months prior to diagnostic LP.
• ✕. Any disease other than refractive error that causes visual loss in the study eyes. Where there is uncertainty this would be determined by the IAC.
• ✕. Refractive error worse than +/- 6.00 sphere or worse than +/- 3.00 cylinder in study eyes. In addition, participants with myopia of worse than -6.00 D sphere but less than or equal to -8.00 D sphere are eligible if the subject wears a contact lens for all perimetry examinations with the appropriate correction.