Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial
NCT ID: NCT04942002
Last Updated: 2021-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2021-06-15
2023-09-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Standard treatment + placebo
2. Standard treatment + intervention
TREATMENT
DOUBLE
Study Groups
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Standard treatment + placebo
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution
Placebo Comparator: Standard treatment + placebo
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider
Standard treatment + intervention
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate
Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]
Retrobulbar injection performed by care provider
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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Asociación para Evitar la Ceguera en México
OTHER
Responsible Party
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Principal Investigators
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Jorge Cárdenas-Belaunzarán, MD, MSc
Role: STUDY_DIRECTOR
Asociación Para Evitar la Ceguera en México I.A.P
Karen Flores-Guevara, MD
Role: PRINCIPAL_INVESTIGATOR
Asociación Para Evitar la Ceguera en México I.A.P
Locations
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Jorge Cárdenas Belaunzarán
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Jorge Cárdenas-Belaunzarán, MD, MSc
Role: primary
References
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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.
Prasad S, Volpe NJ, Balcer LJ. Approach to optic neuropathies: clinical update. Neurologist. 2010 Jan;16(1):23-34. doi: 10.1097/NRL.0b013e3181be6fad.
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.
Costello F. Inflammatory optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):816-37. doi: 10.1212/01.CON.0000453316.60013.52.
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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.
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.
Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of Neuromyelitis Optica. J Neuroophthalmol. 2016 Sep;36(3):238-45. doi: 10.1097/WNO.0000000000000396.
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.
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Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
Jabs DA, Rosenbaum JT, Foster CS, Holland GN, Jaffe GJ, Louie JS, Nussenblatt RB, Stiehm ER, Tessler H, Van Gelder RN, Whitcup SM, Yocum D. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513. doi: 10.1016/s0002-9394(00)00659-0.
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.
Arifulin AA, Burenkov MS, Davidenkov AV, Pichugin VIu, Salimov RM. [Mechanism of the effect of nonionizing radiation on animals at the level of sensory systems]. Radiobiologiia. 1986 Mar-Apr;26(2):247-50. Russian.
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.
Schimek RA, Newsom SR. Restoration of vision in temporal arteritis by retrobulbar injections of steroids. Am J Ophthalmol. 1966 Oct;62(4):693-6. doi: 10.1016/0002-9394(66)92196-9. No abstract available.
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.
Knudsen LL. Retrobulbar injection of methylprednisolone in diffuse diabetic macular edema. Retina. 2004 Dec;24(6):905-9. doi: 10.1097/00006982-200412000-00010.
Hayashi K, Hayashi H. Intravitreal versus retrobulbar injections of triamcinolone for macular edema associated with branch retinal vein occlusion. Am J Ophthalmol. 2005 Jun;139(6):972-82. doi: 10.1016/j.ajo.2004.12.087.
Bordaberry M, Marques DL, Pereira-Lima JC, Marcon IM, Schmid H. Repeated peribulbar injections of triamcinolone acetonide: a successful and safe treatment for moderate to severe Graves' ophthalmopathy. Acta Ophthalmol. 2009 Feb;87(1):58-64. doi: 10.1111/j.1755-3768.2008.01171.x. Epub 2008 Oct 7.
Boniuk V, Nockowitz R. Perforation of the globe during retrobulbar injection: medicolegal aspects of four cases. Surv Ophthalmol. 1994 Sep-Oct;39(2):141-5. doi: 10.1016/0039-6257(94)90159-7.
Raghava S, Hammond M, Kompella UB. Periocular routes for retinal drug delivery. Expert Opin Drug Deliv. 2004 Nov;1(1):99-114. doi: 10.1517/17425247.1.1.99.
Abel AD, Carlson JA, Bakri S, Meyer DR. Sclerosing lipogranuloma of the orbit after periocular steroid injection. Ophthalmology. 2003 Sep;110(9):1841-5. doi: 10.1016/S0161-6420(03)00560-8.
Parikh S, Shanmugam MP, Biswas J. Bisected macula following retrobulbar steroid injection. Indian J Ophthalmol. 1999 Dec;47(4):247-8.
Other Identifiers
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Neu-21-01
Identifier Type: -
Identifier Source: org_study_id
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