Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942002
• Other study ID #: Neu-21-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2021
• Est. completion date: September 15, 2023

Study information

• Verified date: June 2021
• Source: Asociación para Evitar la Ceguera en México
• Contact: Jorge Cárdenas-Belaunzarán, MD, MSc
• Phone: 5510841400
• Email: jorge.cardenas[@]apec.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Methylprednisolone
• Neuritis
• Optic Neuritis
• Treatment

Intervention

Drug:
• Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]
Retrobulbar injection performed by care provider
• Placebo Comparator: Standard treatment + placebo
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider

Locations

Country	Name	City	State
Mexico	Jorge Cárdenas Belaunzarán	Ciudad de mexico

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Visual Capacity	Best corrected visual acuity	Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary	Change from Baseline Color vision	Color vision as measured by Ishihara plates	Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary	Change from Baseline Visual field defect	Visual fields as measured by Goldmann perimetry	Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary	Change from Baseline Oct pRNFL (microns)	Nerve fiber thickness as measured by OCT	2-week visit, 3-month visit