Back to resultsEffect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Primary Purpose
Optic Neuritis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Phenytoin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Eye Research Center Farabi Hosoital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
phenytoin
placebo
Arm Description
patients received phenytoin 100mg three time daily up to 3 months
patients received placebo 100 mg three time daily for 3 months
Outcomes
Primary Outcome Measures
Retinal Ganglion Cell Inner Plexiform Layer Thickness
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Macular Layer Thickness
macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
Best Corrected Visual Acuity
Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
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).
Secondary Outcome Measures
Retinal Nerve Fibre Layer Thickness in Micrometer
Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Full Information
NCT ID
NCT02939937
First Posted
August 8, 2016
Last Updated
July 5, 2019
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02939937
Brief Title
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
November 11, 2018 (Actual)
Study Completion Date
January 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
participant , investigator
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phenytoin
Arm Type
Experimental
Arm Description
patients received phenytoin 100mg three time daily up to 3 months
Arm Title
placebo
Arm Type
Experimental
Arm Description
patients received placebo 100 mg three time daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Phenytoin
Other Intervention Name(s)
epanutin
Intervention Description
100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
Primary Outcome Measure Information:
Title
Retinal Ganglion Cell Inner Plexiform Layer Thickness
Description
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Time Frame
Measured at baseline and month 1, 6
Title
Macular Layer Thickness
Description
macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
Time Frame
Measured at baseline and month 1, 6
Title
Best Corrected Visual Acuity
Description
Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
Time Frame
at baseline and month 6
Title
Visual Field Mean Deviation in Decibel
Description
The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).
Time Frame
Measured at baseline and month 6
Secondary Outcome Measure Information:
Title
Retinal Nerve Fibre Layer Thickness in Micrometer
Description
Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Time Frame
Measured at baseline and month1 ,6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Eye Research Center Farabi Hosoital
City
Tehran
ZIP/Postal Code
3542168325
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
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