Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Study Overview
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Brief Summary
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A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.

Detailed Description
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A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone. Enrollment: 50. Randomized groups (2) Standard treatment + placebo Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Official Title
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Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.

Conditions
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Optic Neuritis, Treatment, Methylprednisolone

Intervention / Treatment
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* Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]
* Drug: Placebo Comparator: Standard treatment + placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genres Age between 18 and 85 years old. Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect) 1 month after symptoms started If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included. if is a bilateral sequential optic neuritis the eye with lees 1 month evolution will be included. Exclusion Criteria: Visual field better than 20/60 at the beginning of the study. History of optic neuritis in the eye under study. History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study. History of previous treatment with intravenous methylprednisolone since the onset of symptoms. History of high myopia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized groups (2) Standard treatment + placebo Standard treatment + intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard treatment + placebo<br>Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution | Drug: Placebo Comparator: Standard treatment + placebo<br>* Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider<br>* Other names: 1. Standard treatment + placebo;|
| Experimental: Standard treatment + intervention<br>Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate | Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]<br>* Retrobulbar injection performed by care provider<br>* Other names: Experimental: Standard treatment + intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Visual Capacity | Best corrected visual acuity | Initial visit, 2-week visit, 1-month visit, 3-month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Color vision | Color vision as measured by Ishihara plates | Initial visit, 2-week visit, 1-month visit, 3-month visit | 
| Change from Baseline Visual field defect | Visual fields as measured by Goldmann perimetry | Initial visit, 2-week visit, 1-month visit, 3-month visit | 
| Change from Baseline Oct pRNFL (microns) | Nerve fiber thickness as measured by OCT | 2-week visit, 3-month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optic Neuritis, Methylprednisolone, Retrobulbar injection