Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Methylprednisolone acetate
Glucocorticoid receptor agonist
Placebo or sham
- Placebo Comparator: Standard treatment + placebo
What it measured
Main measures
Change from Baseline Visual Capacity
Initial visit, 2-week visit, 1-month visit, 3-month visit
Vision
Other measures (3)
Change from Baseline Color vision
Initial visit, 2-week visit, 1-month visit, 3-month visit
VisionChange 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
Retina scans (OCT)
Who could take part
Optic neuritis · 18 to 85
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.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.Background
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.Background
Costello F. Inflammatory optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):816-37. doi: 10.1212/01.CON.0000453316.60013.52.Background
Confino E, Mayden KL, Giglia RV, Vermesh M, Gleicher N. Pitfalls in sonographic imaging of the incompetent uterine cervix. Acta Obstet Gynecol Scand. 1986;65(6):593-7. doi: 10.3109/00016348609158394.Background
Rappoport D, Goldenberg-Cohen N, Luckman J, Leiba H. Parainfectious optic neuritis: manifestations in children vs adults. J Neuroophthalmol. 2014 Jun;34(2):122-9. doi: 10.1097/WNO.0000000000000113.Background
Boudreault K, Durand ML, Rizzo JF 3rd. Investigation-Directed Approach to Inflammatory Optic Neuropathies. Semin Ophthalmol. 2016;31(1-2):117-30. doi: 10.3109/08820538.2015.1114835.Background
Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of Neuromyelitis Optica. J Neuroophthalmol. 2016 Sep;36(3):238-45. doi: 10.1097/WNO.0000000000000396.Background
Abouna GM. Extracorporeal liver perfusion using a new perfusion chamber. Lancet. 1968 Dec 7;2(7580):1216-8. doi: 10.1016/s0140-6736(68)91696-6. No abstract available.Background
Borvak J, Mayer V. UV-absorbance profile of human leukocytic ultrafiltrate after affinity chromatography on immobilized m-aminophenyl boronic acid: implication for transfer factor purification. Acta Virol. 1985 Mar;29(2):119-28.
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History
Started
Jun 2021
Main results due
Jun 2023
Finished
Sept 2023
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