Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02412059
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2015-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009935', 'term': 'prednisolone acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2015-04-03', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of epiretinal membrane', 'timeFrame': '6-months following administration of corticosteroid'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epiretinal Membrane']}, 'referencesModule': {'references': [{'pmid': '25360790', 'type': 'BACKGROUND', 'citation': 'Bu SC, Kuijer R, Li XR, Hooymans JM, Los LI. Idiopathic epiretinal membrane. Retina. 2014 Dec;34(12):2317-35. doi: 10.1097/IAE.0000000000000349.'}, {'pmid': '7573306', 'type': 'BACKGROUND', 'citation': 'Saran BR, Brucker AJ. Macular epiretinal membrane formation and treated retinal breaks. Am J Ophthalmol. 1995 Oct;120(4):480-5. doi: 10.1016/s0002-9394(14)72662-5.'}, {'pmid': '18344963', 'type': 'BACKGROUND', 'citation': 'Snead DR, James S, Snead MP. Pathological changes in the vitreoretinal junction 1: epiretinal membrane formation. Eye (Lond). 2008 Oct;22(10):1310-7. doi: 10.1038/eye.2008.36. Epub 2008 Mar 14.'}, {'pmid': '24324293', 'type': 'BACKGROUND', 'citation': 'Joshi M, Agrawal S, Christoforidis JB. Inflammatory mechanisms of idiopathic epiretinal membrane formation. Mediators Inflamm. 2013;2013:192582. doi: 10.1155/2013/192582. Epub 2013 Nov 11.'}, {'pmid': '3076143', 'type': 'BACKGROUND', 'citation': 'Gilbert C, Hiscott P, Unger W, Grierson I, McLeod D. Inflammation and the formation of epiretinal membranes. Eye (Lond). 1988;2 Suppl:S140-56. doi: 10.1038/eye.1988.140.'}, {'pmid': '3180837', 'type': 'BACKGROUND', 'citation': 'Hiscott PS, Unger WG, Grierson I, McLeod D. The role of inflammation in the development of epiretinal membranes. Curr Eye Res. 1988 Sep;7(9):877-92. doi: 10.3109/02713688808997245.'}, {'pmid': '8106541', 'type': 'BACKGROUND', 'citation': 'Grinnell F. Fibroblasts, myofibroblasts, and wound contraction. J Cell Biol. 1994 Feb;124(4):401-4. doi: 10.1083/jcb.124.4.401. No abstract available.'}, {'pmid': '23406256', 'type': 'BACKGROUND', 'citation': 'Banerjee PJ, Woodcock MG, Bunce C, Scott R, Charteris DG. A pilot study of intraocular use of intensive anti-inflammatory; triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma; the Adjuncts in Ocular Trauma (AOT) Trial: study protocol for a randomised controlled trial. Trials. 2013 Feb 13;14:42. doi: 10.1186/1745-6215-14-42.'}, {'pmid': '6153251', 'type': 'BACKGROUND', 'citation': 'Tano Y, Sugita G, Abrams G, Machemer R. Inhibition of intraocular proliferations with intravitreal corticosteroids. Am J Ophthalmol. 1980 Jan;89(1):131-6. doi: 10.1016/0002-9394(80)90239-1.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective randomized controlled double blind pilot clinical study, we aim to assess whether administration of a topical corticosteroid would attenuate epiretinal membrane formation following development of retinal tears treated with laser retionpexy.', 'detailedDescription': 'Epiretinal membrane (ERM) is a frequent, sight-threatening eye condition occurring in 1.02% - 28.9% of eyes in persons aged 40 years or older. \\[1\\] While often idiopathic in nature, ERM formation has been associated with retinal tears, possibly due to a breakdown of the blood-retinal barrier \\[1-3\\]. Pathological analysis of ERM content shows inflammatory mediators such as cytokines, growth factors and interleukins, which can promote fibroblast remodelling that leads to a contractile scar formation on the retinal surface. \\[1, 4-8\\] For this reason, ERM formation has been suggested to be an aberrant tissue repair or wound-healing process driven by inflammatory reactions. Since corticosteroids inhibit the inflammatory cascade and fibroblast transdifferentiation, administration of a corticosteroid following retinal tears should theoretically reduce the risk of ERM formation. \\[9-10\\] In this study, we aim to assess whether administration of a topical corticosteroid would attenuate ERM formation following laser retinopexy of retinal tears.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 18 to 80 (inclusive)\n* English-speaking\n* Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment)\n\nExclusion Criteria:\n\n* Patient refusal or delay of retinopexy procedure for more than 48 hours after diagnosis\n* Patients who are pseudophakic or aphakic\n* Medical conditions contraindicated with prednisolone: viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fundal diseases of ocular structures; mycobacterial infections; hypercortisolism.\n* Previous history of epiretinal membrane, retinal surgery (cryo or laser)\n* Patients with hypersensitivity or contraindication for corticosteroids (viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fungal diseases of ocular structures; mycobacterial infections; hypercortisolism).'}, 'identificationModule': {'nctId': 'NCT02412059', 'briefTitle': 'Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study', 'orgStudyIdInfo': {'id': 'LichterM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prednisolone', 'description': 'Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile', 'interventionNames': ['Drug: Prednisolone acetate']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in control group will not be given a corticosteroid as per usual standard of care.'}], 'interventions': [{'name': 'Prednisolone acetate', 'type': 'DRUG', 'otherNames': ['Pred Forte'], 'armGroupLabels': ['Prednisolone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Myrna Lichter, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto Department of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}