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Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Primary Purpose

Optic Neuritis, Treatment, Methylprednisolone

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]

Placebo Comparator: Standard treatment + placebo

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Optic Neuritis, Methylprednisolone, Retrobulbar injection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Jorge Cárdenas BelaunzaránRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard treatment + placebo

Standard treatment + intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline Visual Capacity

Best corrected visual acuity

Secondary Outcome Measures

Change from Baseline Color vision

Color vision as measured by Ishihara plates

Change from Baseline Visual field defect

Visual fields as measured by Goldmann perimetry

Change from Baseline Oct pRNFL (microns)

Nerve fiber thickness as measured by OCT

Full Information

NCT ID

NCT04942002

First Posted

June 15, 2021

Last Updated

June 18, 2021

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT04942002

Brief Title

Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 15, 2021 (Anticipated)

Primary Completion Date

June 15, 2023 (Anticipated)

Study Completion Date

September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Optic Neuritis, Treatment, Methylprednisolone

Keywords

Optic Neuritis, Methylprednisolone, Retrobulbar injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard treatment + placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Standard treatment + intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]

Other Intervention Name(s)

Experimental: Standard treatment + intervention

Intervention Description

Retrobulbar injection performed by care provider

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator: Standard treatment + placebo

Other Intervention Name(s)

1. Standard treatment + placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline Visual Capacity

Description

Best corrected visual acuity

Time Frame

Initial visit, 2-week visit, 1-month visit, 3-month visit

Secondary Outcome Measure Information:

Title

Change from Baseline Color vision

Description

Color vision as measured by Ishihara plates

Time Frame

Initial visit, 2-week visit, 1-month visit, 3-month visit

Title

Change from Baseline Visual field defect

Description

Visual fields as measured by Goldmann perimetry

Time Frame

Initial visit, 2-week visit, 1-month visit, 3-month visit

Title

Change from Baseline Oct pRNFL (microns)

Description

Nerve fiber thickness as measured by OCT

Time Frame

2-week visit, 3-month visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jorge Cárdenas-Belaunzarán, MD, MSc

Phone

5510841400

Ext

1207

jorge.cardenas@apec.com.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Flores-Guevara, MD

Phone

2299849589

karen.fguevara@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Cárdenas-Belaunzarán, MD, MSc

Organizational Affiliation

Asociación Para Evitar la Ceguera en México I.A.P

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Karen Flores-Guevara, MD

Organizational Affiliation

Asociación Para Evitar la Ceguera en México I.A.P

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jorge Cárdenas Belaunzarán

City

Ciudad de mexico

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Cárdenas-Belaunzarán, MD, MSc

Phone

5510841400

Ext

1207

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This study is confidential and no information will be shared with the participants.

Citations:

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Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

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