Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

NCT04942002 | Unknown Phase 2 DMC

• 1 other identifier: Neu-21-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuritis; Treatment; Methylprednisolone

Keywords

Optic Neuritis; Methylprednisolone; Retrobulbar injection

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Visual Capacity

  Best corrected visual acuity

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

Secondary Outcomes (3)

• Change from Baseline Color vision

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

• Change from Baseline Visual field defect

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

• Change from Baseline Oct pRNFL (microns)

  2-week visit, 3-month visit

Study Arms (2)

Standard treatment + placebo

PLACEBO COMPARATOR

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

Drug: Placebo Comparator: Standard treatment + placebo

Standard treatment + intervention

EXPERIMENTAL

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]

Interventions

Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] DRUG

Retrobulbar injection performed by care provider

Also known as: Experimental: Standard treatment + intervention

Standard treatment + intervention

Placebo Comparator: Standard treatment + placebo DRUG

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

Also known as: 1. Standard treatment + placebo

Standard treatment + placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genres
• Age between 18 and 85 years old.
• Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Jorge Cárdenas Belaunzarán

Mexico City, 04030, Mexico

RECRUITING

Related Publications (24)

• Yau GS, Lee JW, Lau PP, Tam VT, Wong WW, Yuen CY. Longitudinal Changes in Retinal Nerve Fibre Layer Thickness after an Isolated Unilateral Retrobulbar Optic Neuritis: 1-Year Results. Neuroophthalmology. 2015 Jan 22;39(1):22-25. doi: 10.3109/01658107.2014.984230. eCollection 2015 Feb.

  PMID: 27928326 BACKGROUND

• Prasad S, Volpe NJ, Balcer LJ. Approach to optic neuropathies: clinical update. Neurologist. 2010 Jan;16(1):23-34. doi: 10.1097/NRL.0b013e3181be6fad.

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• Van Stavern GP. Metabolic, hereditary, traumatic, and neoplastic optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):877-906. doi: 10.1212/01.CON.0000453313.37143.9b.

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• Jermak CM, Dellacroce JT, Heffez J, Peyman GA. Triamcinolone acetonide in ocular therapeutics. Surv Ophthalmol. 2007 Sep-Oct;52(5):503-22. doi: 10.1016/j.survophthal.2007.06.004.

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• Rawson MD, Liversedge LA, Goldfarb G. Treatment of acute retrobulbar neuritis with corticotrophin. Lancet. 1966 Nov 12;2(7472):1044-6. doi: 10.1016/s0140-6736(66)92025-3. No abstract available.

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• Gould ES, Bird AC, Leaver PK, McDonald WI. Treatmenf of optic neuritis by retrobulbar injection of triamcinolone. Br Med J. 1977 Jun 11;1(6075):1495-7. doi: 10.1136/bmj.1.6075.1495.

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• Knudsen LL. Retrobulbar injection of methylprednisolone in diffuse diabetic macular edema. Retina. 2004 Dec;24(6):905-9. doi: 10.1097/00006982-200412000-00010.

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MeSH Terms

Conditions

Optic Neuritis

Interventions

Methylprednisolone Acetate; Methods

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Investigative Techniques

Study Officials

• Jorge Cárdenas-Belaunzarán, MD, MSc

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

  STUDY DIRECTOR

• Karen Flores-Guevara, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Cárdenas-Belaunzarán, MD, MSc

CONTACT

5510841400; jorge.cardenas@apec.com.mx

Karen Flores-Guevara, MD

CONTACT

2299849589; karen.fguevara@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized groups (2) 1. Standard treatment + placebo 2. Standard treatment + intervention

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 28, 2021
• Study Start: June 15, 2021
• Primary Completion: June 15, 2023
• Study Completion: September 15, 2023
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)