Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Recruiting

CT.gov ID

NCT04942002

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Optic Neuritis Treatment Methylprednisolone	Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] Drug: Placebo Comparator: Standard treatment + placebo	Phase 2/Phase 3

Detailed Description

Enrollment: 50. Randomized groups (2)

Standard treatment + placebo
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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized groups (2) Standard treatment + placebo Standard treatment + interventionRandomized groups (2) Standard treatment + placebo Standard treatment + intervention

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard treatment + placebo Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution	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 Other Names: 1. Standard treatment + placebo
Experimental: Standard treatment + intervention Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate	Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] Retrobulbar injection performed by care provider Other Names: Experimental: Standard treatment + intervention

Arm

Intervention/Treatment

Placebo Comparator: Standard treatment + placebo

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

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

Other Names:

1. Standard treatment + placebo

Experimental: Standard treatment + intervention

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

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

Retrobulbar injection performed by care provider

Other Names:

Experimental: Standard treatment + intervention

Outcome Measures

Primary Outcome Measures

Change from Baseline Visual Capacity [Initial visit, 2-week visit, 1-month visit, 3-month visit]
Best corrected visual acuity

Secondary Outcome Measures

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 Visual field defect [Initial visit, 2-week visit, 1-month visit, 3-month visit]
Visual fields as measured by Goldmann perimetry
Change from Baseline Oct pRNFL (microns) [2-week visit, 3-month visit]
Nerve fiber thickness as measured by OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jorge Cárdenas Belaunzarán	Ciudad de mexico		Mexico	04030

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Investigators

Study Director: Jorge Cárdenas-Belaunzarán, MD, MSc, Asociación Para Evitar la Ceguera en México I.A.P
Principal Investigator: Karen Flores-Guevara, MD, Asociación Para Evitar la Ceguera en México I.A.P