Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Phase 2

• Conditions: Optic Neuritis; Treatment; Methylprednisolone
• Interventions: Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]

• Registration Number: NCT04942002
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief Summary

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

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

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-15
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Study First Posted: 2021-06-28
• Last Update Posted: 2021-06-28
• Primary Completion: 2023-06-15
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment + intervention	Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]	Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate

Primary Outcome Measures

Name	Time	Method
Change from Baseline Visual Capacity	Initial visit, 2-week visit, 1-month visit, 3-month visit	Best corrected visual acuity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jorge Cárdenas Belaunzarán; 🇲🇽 Ciudad de mexico, Mexico