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

Optic Neuritis Clinical Trial

Official title:

a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939937
• Other study ID #: 9411257013
• Status: Completed
• Phase: Phase 2
• Start date: March 9, 2017
• Est. completion date: January 2, 2019

Study information

• Verified date: April 2018
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2, 2019
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Drug:
• Phenytoin
100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
• placebo
100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Eye Research Center Farabi Hosoital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal Ganglion Cell Inner Plexiform Layer Thickness	ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography	Measured at baseline and month 1, 6
Primary	Macular Layer Thickness	macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography	Measured at baseline and month 1, 6
Primary	Best Corrected Visual Acuity	Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.	at baseline and month 6
Primary	Visual Field Mean Deviation in Decibel	The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).	Measured at baseline and month 6
Secondary	Retinal Nerve Fibre Layer Thickness in Micrometer	Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography	Measured at baseline and month1 ,6