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)

Abel AD, Carlson JA, Bakri S, Meyer DR. Sclerosing lipogranuloma of the orbit after periocular steroid injection. Ophthalmology. 2003 Sep;110(9):1841-5. — View Citation

Abouna GM. Extracorporeal liver perfusion using a new perfusion chamber. Lancet. 1968 Dec 7;2(7580):1216-8. — View Citation

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. — View Citation

Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of Neuromyelitis Optica. J Neuroophthalmol. 2016 Sep;36(3):238-45. doi: 10.1097/WNO.0000000000000396. Review. — View Citation

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. — View Citation

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. — View Citation

Borvák 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. — View Citation

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. Review. — View Citation

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. — View Citation

Costello F. Inflammatory optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):816-37. doi: 10.1212/01.CON.0000453316.60013.52. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Jermak CM, Dellacroce JT, Heffez J, Peyman GA. Triamcinolone acetonide in ocular therapeutics. Surv Ophthalmol. 2007 Sep-Oct;52(5):503-22. Review. — View Citation

Knudsen LL. Retrobulbar injection of methylprednisolone in diffuse diabetic macular edema. Retina. 2004 Dec;24(6):905-9. — View Citation

Parikh S, Shanmugam MP, Biswas J. Bisected macula following retrobulbar steroid injection. Indian J Ophthalmol. 1999 Dec;47(4):247-8. — View Citation

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

Raghava S, Hammond M, Kompella UB. Periocular routes for retinal drug delivery. Expert Opin Drug Deliv. 2004 Nov;1(1):99-114. Review. — View Citation

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. — View Citation

Rawson MD, Liversedge LA, Goldfarb G. Treatment of acute retrobulbar neuritis with corticotrophin. Lancet. 1966 Nov 12;2(7472):1044-6. — View Citation

Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. Review. — View Citation

Schimek RA, Newsom SR. Restoration of vision in temporal arteritis by retrobulbar injections of steroids. Am J Ophthalmol. 1966 Oct;62(4):693-6. — View Citation

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. Review. Erratum in: Continuum (Minneap Minn). 2014 Oct;20:1173-4. — View Citation

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. eCollection 2015 Feb. — View Citation

* 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