Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04942002
Status:
UNKNOWN
Last Update Posted:
2021-06-28
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized groups (2)\n\n1. Standard treatment + placebo\n2. Standard treatment + intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-18', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Visual Capacity', 'timeFrame': 'Initial visit, 2-week visit, 1-month visit, 3-month visit', 'description': 'Best corrected visual acuity'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Color vision', 'timeFrame': 'Initial visit, 2-week visit, 1-month visit, 3-month visit', 'description': 'Color vision as measured by Ishihara plates'}, {'measure': 'Change from Baseline Visual field defect', 'timeFrame': 'Initial visit, 2-week visit, 1-month visit, 3-month visit', 'description': 'Visual fields as measured by Goldmann perimetry'}, {'measure': 'Change from Baseline Oct pRNFL (microns)', 'timeFrame': '2-week visit, 3-month visit', 'description': 'Nerve fiber thickness as measured by OCT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optic Neuritis', 'Methylprednisolone', 'Retrobulbar injection'], 'conditions': ['Optic Neuritis', 'Treatment', 'Methylprednisolone']}, 'referencesModule': {'references': [{'pmid': '27928326', 'type': 'BACKGROUND', '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. doi: 10.3109/01658107.2014.984230. eCollection 2015 Feb.'}, {'pmid': '20065793', 'type': 'BACKGROUND', '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.'}, {'pmid': '25099099', 'type': 'BACKGROUND', '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.'}, {'pmid': '25099096', 'type': 'BACKGROUND', '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.'}, {'pmid': '3541483', 'type': 'BACKGROUND', '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. doi: 10.3109/00016348609158394.'}, {'pmid': '24667772', 'type': 'BACKGROUND', '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.'}, {'pmid': '26959137', 'type': 'BACKGROUND', '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.'}, {'pmid': '27529327', 'type': 'BACKGROUND', '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.'}, {'pmid': '4177207', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2860795', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16236742', 'type': 'BACKGROUND', '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. doi: 10.1056/NEJMra050541. No abstract available.'}, {'pmid': '11024423', 'type': 'BACKGROUND', '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. doi: 10.1016/s0002-9394(00)00659-0.'}, {'pmid': '17719372', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3704120', 'type': 'BACKGROUND', '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.'}, {'pmid': '4162503', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '5929135', 'type': 'BACKGROUND', '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. doi: 10.1016/0002-9394(66)92196-9. No abstract available.'}, {'pmid': '326332', 'type': 'BACKGROUND', '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. doi: 10.1136/bmj.1.6075.1495.'}, {'pmid': '15579988', 'type': 'BACKGROUND', 'citation': 'Knudsen LL. Retrobulbar injection of methylprednisolone in diffuse diabetic macular edema. Retina. 2004 Dec;24(6):905-9. doi: 10.1097/00006982-200412000-00010.'}, {'pmid': '15953425', 'type': 'BACKGROUND', '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. doi: 10.1016/j.ajo.2004.12.087.'}, {'pmid': '18937809', 'type': 'BACKGROUND', '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."}, {'pmid': '7801222', 'type': 'BACKGROUND', '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. doi: 10.1016/0039-6257(94)90159-7.'}, {'pmid': '16296723', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '13129887', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10892482', 'type': 'BACKGROUND', 'citation': 'Parikh S, Shanmugam MP, Biswas J. Bisected macula following retrobulbar steroid injection. Indian J Ophthalmol. 1999 Dec;47(4):247-8.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nEnrollment: 50. Randomized groups (2)\n\n1. Standard treatment + placebo\n2. 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genres\n* Age between 18 and 85 years old.\n* Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect)\n* 1 month after symptoms started\n* If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included.\n* if is a bilateral sequential optic neuritis the eye with lees 1 month evolution will be included.\n\nExclusion Criteria:\n\n* Visual field better than 20/60 at the beginning of the study.\n* History of optic neuritis in the eye under study.\n* History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study.\n* History of previous treatment with intravenous methylprednisolone since the onset of symptoms.\n* History of high myopia.'}, 'identificationModule': {'nctId': 'NCT04942002', 'briefTitle': 'Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Neu-21-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard treatment + placebo', 'description': 'Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution', 'interventionNames': ['Drug: Placebo Comparator: Standard treatment + placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Standard treatment + intervention', 'description': 'Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate', 'interventionNames': ['Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]']}], 'interventions': [{'name': 'Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]', 'type': 'DRUG', 'otherNames': ['Experimental: Standard treatment + intervention'], 'description': 'Retrobulbar injection performed by care provider', 'armGroupLabels': ['Standard treatment + intervention']}, {'name': 'Placebo Comparator: Standard treatment + placebo', 'type': 'DRUG', 'otherNames': ['1. Standard treatment + placebo'], 'description': 'Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider', 'armGroupLabels': ['Standard treatment + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Jorge Cárdenas-Belaunzarán, MD, MSc', 'role': 'CONTACT', 'phone': '5510841400', 'phoneExt': '1207'}], 'facility': 'Jorge Cárdenas Belaunzarán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Jorge Cárdenas-Belaunzarán, MD, MSc', 'role': 'CONTACT', 'email': 'jorge.cardenas@apec.com.mx', 'phone': '5510841400', 'phoneExt': '1207'}, {'name': 'Karen Flores-Guevara, MD', 'role': 'CONTACT', 'email': 'karen.fguevara@hotmail.com', 'phone': '2299849589'}], 'overallOfficials': [{'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', 'affiliation': 'Asociación Para Evitar la Ceguera en México I.A.P'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study is confidential and no information will be shared with the participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}