Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

• Status: Recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asociación para Evitar la Ceguera en México
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.