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Status unknownNCT04942002Updated Jun 28, 2021

Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

A Phase 2/3 interventional study of Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] and Placebo Comparator: Standard treatment + placebo in Optic Neuritis, Treatment and Methylprednisolone, sponsored by Asociación para Evitar la Ceguera en México. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-28.

Sponsored by Asociación para Evitar la Ceguera en México · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Optic Neuritis
  • Treatment
  • Methylprednisolone

Keywords

  • Optic Neuritis
  • Methylprednisolone
  • Retrobulbar injection
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Placebo comparator
    Standard treatment + placebo

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

    Drug: Placebo Comparator: Standard treatment + placebo

  • Experimental
    Standard treatment + intervention

    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

  • DrugMethylprednisolone Acetate 40 MG/ML [Depo-Medrol]

    Retrobulbar injection performed by care provider

    Also known as: Experimental: Standard treatment + intervention

  • DrugPlacebo Comparator: Standard treatment + placebo

    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

05

What researchers measure

Primary outcomes

  1. Change from Baseline Visual Capacity

    Best corrected visual acuity

    Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit

Secondary outcomes

  1. Change from Baseline Color vision

    Color vision as measured by Ishihara plates

    Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit

  2. Change from Baseline Visual field defect

    Visual fields as measured by Goldmann perimetry

    Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit

  3. Change from Baseline Oct pRNFL (microns)

    Nerve fiber thickness as measured by OCT

    Time frame: 2-week visit, 3-month visit

06

Study locations

1 of 1 sites recruiting
  • Jorge Cárdenas Belaunzarán
    Ciudad de mexico, 04030, Mexico
    • Jorge Cárdenas-Belaunzarán, MD, MSc · Contact · 5510841400
    Recruiting
07

References and documents

Publications

  • 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. PubMed 27928326 ↗
  • Prasad S, Volpe NJ, Balcer LJ. Approach to optic neuropathies: clinical update. Neurologist. 2010 Jan;16(1):23-34. doi: 10.1097/NRL.0b013e3181be6fad. PubMed 20065793 ↗
  • 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. Erratum In: Continuum (Minneap Minn). 2014 Oct;20:1173-4. PubMed 25099099 ↗
  • Costello F. Inflammatory optic neuropathies. Continuum (Minneap Minn). 2014 Aug;20(4 Neuro-ophthalmology):816-37. doi: 10.1212/01.CON.0000453316.60013.52. PubMed 25099096 ↗
  • 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. PubMed 3541483 ↗
  • 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. PubMed 24667772 ↗
  • 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. PubMed 26959137 ↗
  • Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of Neuromyelitis Optica. J Neuroophthalmol. 2016 Sep;36(3):238-45. doi: 10.1097/WNO.0000000000000396. PubMed 27529327 ↗
  • 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. PubMed 4177207 ↗
  • 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. PubMed 2860795 ↗
  • 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. PubMed 16236742 ↗
  • 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. PubMed 11024423 ↗
  • 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. PubMed 17719372 ↗
  • 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. PubMed 3704120 ↗
  • 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. PubMed 4162503 ↗
  • 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. PubMed 5929135 ↗
  • 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. PubMed 326332 ↗
  • Knudsen LL. Retrobulbar injection of methylprednisolone in diffuse diabetic macular edema. Retina. 2004 Dec;24(6):905-9. doi: 10.1097/00006982-200412000-00010. PubMed 15579988 ↗
  • 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. PubMed 15953425 ↗
  • 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. PubMed 18937809 ↗
  • 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. PubMed 7801222 ↗
  • 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. PubMed 16296723 ↗
  • 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. PubMed 13129887 ↗
  • Parikh S, Shanmugam MP, Biswas J. Bisected macula following retrobulbar steroid injection. Indian J Ophthalmol. 1999 Dec;47(4):247-8. PubMed 10892482 ↗

Individual participant data

Plan to share: No — This study is confidential and no information will be shared with the participants.

08

Registry details

Key details

Study ID
NCT04942002
Lead sponsor
Asociación para Evitar la Ceguera en México
Responsible party
Sponsor
First posted
Jun 28, 2021
Start date
Jun 15, 2021 (estimated)
Primary completion
Jun 15, 2023 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
Jun 28, 2021

Study contacts

Jorge Cárdenas-Belaunzarán, MD, MSc
Contact
jorge.cardenas@apec.com.mx
5510841400 ext. 1207
Karen Flores-Guevara, MD
Contact
karen.fguevara@hotmail.com
2299849589
Jorge Cárdenas-Belaunzarán, MD, MSc
study director · Asociación Para Evitar la Ceguera en México I.A.P
Karen Flores-Guevara, MD
principal investigator · Asociación Para Evitar la Ceguera en México I.A.P

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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