Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 2 N=71 Quadruple-blind Treatment

Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis

Optic Neuritis

Bottom Line

View on ClinicalTrials.gov: NCT02939937 ↗
Enrolled (actual)
71
Serious AEs
1.4%
Results posted
Aug 2019
Primary outcome: Primary: Retinal Ganglion Cell Inner Plexiform Layer Thickness — 36.56; 34.65; 31; 29.42 micron

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Phenytoin (Drug); placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Tehran University of Medical Sciences
Primary completion
Nov 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Retinal Ganglion Cell Inner Plexiform Layer Thickness		 36.56; 34.65; 31; 29.42; 30.70; 32.12 —
PRIMARY
Macular Layer Thickness		 262.73; 265.98; 255; 264.39; 269; 268.37 —
PRIMARY
Best Corrected Visual Acuity		 1.44; 1; 0.04; 0.13 —
PRIMARY
Visual Field Mean Deviation in Decibel		 -17.07; -17.76; -3.89; -5.16 —
SECONDARY
Retinal Nerve Fibre Layer Thickness in Micrometer		 131.8; 124.87; 93.85; 97.41; 77.7; 78.61 —

Summary

Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days. As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision. There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage. The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.

Eligibility Criteria

Inclusion Criteria

  • isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
  • willing to receive a steroidal regimen
  • no pathologic finding in first oct
  • no pathology and history of optic neuritis in contralateral eye
  • <14 days since onset visual loss

Exclusion Criteria

  • Contraindication or known allergy to Phenytoin
  • Use of a calcium channel or sodium channel blocker in the past 2 months
  • Corticosteroid use in the past 2 months
  • Pregnancy
  • Significant cardiac, renal or liver abnormalities
  • Prior clinical episode of optic neuritis in either eye
  • Bilateral acute optic neuritis
  • Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
  • Refractive error of greater than +5 or -5 diopters
  • Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02939937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search