Clinical trial NCT04942002: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Optic Neuritis
Treatment
Methylprednisolone
Keywords: Optic Neuritis
Methylprednisolone
Retrobulbar injection
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized groups (2)

1. Standard treatment + placebo
2. Standard treatment + intervention
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Change from Baseline Visual Capacity
timeFrame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary outcomes:
measure: Change from Baseline Color vision
timeFrame: Initial visit, 2-week visit, 1-month visit, 3-month visit
measure: Change from Baseline Visual field defect
timeFrame: Initial visit, 2-week visit, 1-month visit, 3-month visit
measure: Change from Baseline Oct pRNFL (microns)
timeFrame: 2-week visit, 3-month visit
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Jorge Cárdenas Belaunzarán
Study officials:
affiliation: Asociación Para Evitar la Ceguera en México I.A.P
name: Jorge Cárdenas-Belaunzarán, MD, MSc
role: STUDY_DIRECTOR
affiliation: Asociación Para Evitar la Ceguera en México I.A.P
name: Karen Flores-Guevara, MD
role: PRINCIPAL_INVESTIGATOR
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