Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Asociación para Evitar la Ceguera en México

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Treatment; Methylprednisolone; Optic Neuritis

Treatments: Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]; Drug: Placebo Comparator: Standard treatment + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04942002

Neu-21-01

Details and patient eligibility

About

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 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Standard treatment + placebo

Placebo Comparator group

Description:

Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution

Treatment:

Drug: Placebo Comparator: Standard treatment + placebo

Standard treatment + intervention

Experimental group

Description:

Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate

Treatment:

Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]