Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT01131533
Status:
UNKNOWN
Last Update Posted:
2010-09-15
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-14', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of erythropoietin in aqueous humor', 'timeFrame': 'a few seconds', 'description': 'erythropoietin injections had been performed in our department following standard procedures. In selected cases,vitrectomy was performed one to two days after erythropoietin injection to treat diabetic macular edema.During surgery, aqueous humor samples were obtained via a corneal paracentesis anterior to the limbus at the beginning of the procedure.'}], 'secondaryOutcomes': [{'measure': 'Concentration of erythropoietin in vitreous', 'timeFrame': 'few minutes', 'description': 'erythropoietin injections had been performed in our department following standard procedures. In selected cases,vitrectomy was performed one to two days after erythropoietin injection to treat diabetic macular edema.During surgery, vitreous samples were obtained via vitreous cutter at the beginning of the procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pharmacokinetics', 'Erythropoietin']}, 'referencesModule': {'references': [{'pmid': '20128565', 'type': 'RESULT', 'citation': 'Li W, Sinclair SH, Xu GT. Effects of intravitreal erythropoietin therapy for patients with chronic and progressive diabetic macular edema. Ophthalmic Surg Lasers Imaging. 2010 Jan-Feb;41(1):18-25. doi: 10.3928/15428877-20091230-03.'}, {'pmid': '19692373', 'type': 'RESULT', 'citation': 'Lagreze WA, Feltgen N, Bach M, Jehle T. Feasibility of intravitreal erythropoietin injections in humans. Br J Ophthalmol. 2009 Dec;93(12):1667-71. doi: 10.1136/bjo.2008.156794. Epub 2009 Aug 18.'}, {'pmid': '18798078', 'type': 'RESULT', 'citation': 'Song BJ, Cai H, Tsai JC, Chang S, Forbes M, Del Priore LV. Intravitreal recombinant human erythropoietin: a safety study in rabbits. Curr Eye Res. 2008 Sep;33(9):750-60. doi: 10.1080/02713680802366602.'}, {'pmid': '18235022', 'type': 'RESULT', 'citation': 'Zhang J, Wu Y, Jin Y, Ji F, Sinclair SH, Luo Y, Xu G, Lu L, Dai W, Yanoff M, Li W, Xu GT. Intravitreal injection of erythropoietin protects both retinal vascular and neuronal cells in early diabetes. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):732-42. doi: 10.1167/iovs.07-0721.'}, {'pmid': '21819507', 'type': 'DERIVED', 'citation': 'Lim JW, Han JR. Aqueous humour levels of vascular endothelial growth factor and erythropoietin in patients with diabetic macular oedema before and after intravitreal erythropoietin injection. Clin Exp Ophthalmol. 2011 Aug;39(6):537-44. doi: 10.1111/j.1442-9071.2011.02510.x. Epub 2011 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The investigators investigate intraocular concentrations and pharmacokinetics of erythropoietin after a single intravitreal injection in humans.', 'detailedDescription': 'Intravitreal injections of erythropoietin for off-label use have been shown to be beneficial in eyes with diabetic macular edema.However, the pharmacokinetic profile of erythropoietin after intravitreal injection in humans has not yet been determined clearly. The purpose of this study was to determine the intraocular pharmacokinetics of erythropoietin after a single intravitreal injection in a prospective investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic macular edema that failed to respond to or recurred after the previous macular focal laser photocoagulation or intravitreal therapy, or both.\n* visual acuity worse than 40/200 snellen bisual acuity\n\nExclusion Criteria:\n\n* Eyes with vitreomacular traction, active proliferative diabetic retinopathy, intraocular inflammation, uncontrolled intraocular pressure , cataract surgery within the past six months, or a prior history of vitreoretinal surgery'}, 'identificationModule': {'nctId': 'NCT01131533', 'briefTitle': 'Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human', 'orgStudyIdInfo': {'id': '2010_134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin', 'description': 'patients with chronic macular edema associated with diabetic retinopathy', 'interventionNames': ['Procedure: Vitrectomy']}], 'interventions': [{'name': 'Vitrectomy', 'type': 'PROCEDURE', 'description': 'vitrectomy following intravitreal erythropoietin', 'armGroupLabels': ['Erythropoietin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-704', 'city': 'Chuncheon', 'state': 'Kangwondo', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JiWon Lim', 'role': 'CONTACT', 'email': 'jiwoneye@hallym.or.kr', 'phone': '82-33-240-5176'}], 'facility': 'Hallym University Sacred Heart Hoapital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'centralContacts': [{'name': 'JiWon Lim', 'role': 'CONTACT', 'email': 'jiwoneye@hallym.or.kr', 'phone': '82-33-240-5176'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'hallym unuversity medical center', 'oldOrganization': 'department of ophthalmology'}}}}