Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

June 18, 2021 updated by: Asociación para Evitar la Ceguera en México

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

  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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Ciudad de mexico, Mexico, 04030
        • Recruiting
        • Jorge Cárdenas Belaunzarán
        • Contact:
          • Jorge Cárdenas-Belaunzarán, MD, MSc
          • Phone Number: 1207 5510841400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Visual Capacity
Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Best corrected visual acuity
Initial visit, 2-week visit, 1-month visit, 3-month visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Color vision
Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Color vision as measured by Ishihara plates
Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Visual fields as measured by Goldmann perimetry
Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Time Frame: 2-week visit, 3-month visit
Nerve fiber thickness as measured by OCT
2-week visit, 3-month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2021

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neu-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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