Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Overview

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.

Full Title of Study: “Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 15, 2023

Detailed Description

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) 1. Standard treatment + placebo 2. 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

Interventions

  • Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]
    • Retrobulbar injection performed by care provider
  • Drug: Placebo Comparator: Standard treatment + placebo
    • Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider

Arms, Groups and Cohorts

  • Placebo Comparator: Standard treatment + placebo
    • Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution
  • Experimental: Standard treatment + intervention
    • Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline Visual Capacity
    • Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
    • Best corrected visual acuity

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Asociación para Evitar la Ceguera en México
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jorge Cárdenas-Belaunzarán, MD, MSc, Study Director, Asociación Para Evitar la Ceguera en México I.A.P
    • Karen Flores-Guevara, MD, Principal Investigator, Asociación Para Evitar la Ceguera en México I.A.P
  • Overall Contact(s)
    • Jorge Cárdenas-Belaunzarán, MD, MSc, 5510841400, jorge.cardenas@apec.com.mx

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