NCT04942002

Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Asociación para Evitar la Ceguera en México · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Optic Neuritis
• Treatment
• Methylprednisolone

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-15
• Primary completion: 2023-06-15
• Completion: 2023-09-15
• First posted: 2021-06-28
• Last updated: 2021-06-28

Locations

1 site across 1 country: Mexico