Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 11:55 AM
Study NCT ID:
NCT03821168
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2018-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-02', 'studyFirstSubmitDate': '2018-12-27', 'studyFirstSubmitQcDate': '2019-01-26', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'best corrected visual acuity', 'timeFrame': '1 month', 'description': 'Snellen chart'}], 'secondaryOutcomes': [{'measure': 'Optical coherence tomography', 'timeFrame': '1 month', 'description': 'Optical coherence tomography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '31401683', 'type': 'DERIVED', 'citation': 'Entezari M, Flavarjani ZK, Ramezani A, Nikkhah H, Karimi S, Moghadam HF, Daftarian N, Yaseri M. Combination of intravitreal bevacizumab and erythropoietin versus intravitreal bevacizumab alone for refractory diabetic macular edema: a randomized double-blind clinical trial. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2375-2380. doi: 10.1007/s00417-019-04383-2. Epub 2019 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .\n\nProcess of degeneration begins from first hours of RD establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .\n\nHow to stop this phenomena and neuroprotective agent role in this issue are a new interest of researches.\n\nIn the study investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with refractory diabetic macular edema at least one month after third injection\n\nExclusion Criteria:\n\n* previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage'}, 'identificationModule': {'nctId': 'NCT03821168', 'briefTitle': 'The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema', 'orgStudyIdInfo': {'id': '95287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intravitreal injection of bevacizumab and erythropoietin', 'description': 'erythropoietin:', 'interventionNames': ['Drug: injection of bevacizumab and erythropoietin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intravitreal injection of bevacizumab', 'description': 'bevacizumab:1.25 mg', 'interventionNames': ['Drug: injection of bevacizumab']}], 'interventions': [{'name': 'injection of bevacizumab and erythropoietin', 'type': 'DRUG', 'description': 'injection of bevacizumab and erythropoietin', 'armGroupLabels': ['intravitreal injection of bevacizumab and erythropoietin']}, {'name': 'injection of bevacizumab', 'type': 'DRUG', 'description': 'under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness', 'armGroupLabels': ['intravitreal injection of bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Morteza Entzari, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}], 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Morteza Entezari, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zahra Rabbani Khah', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}