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Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

NCT04942002 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-06-28

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Asociación para Evitar la Ceguera en México

    lead OTHER

Principal Investigators

  • Jorge Cárdenas-Belaunzarán, MD, MSc · Asociación Para Evitar la Ceguera en México I.A.P

  • Karen Flores-Guevara, MD · Asociación Para Evitar la Ceguera en México I.A.P

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-06-15
Completion
2023-09-15

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04942002 on ClinicalTrials.gov