Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 9:57 AM
Study NCT ID:
NCT03863535
Status:
UNKNOWN
Last Update Posted:
2019-03-05
First Post:
2019-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRP vs PRP+IVC for Severe nPDR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527363', 'term': 'KH902 fusion protein'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-03', 'studyFirstSubmitDate': '2019-01-27', 'studyFirstSubmitQcDate': '2019-03-03', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in best-corrected visual acuity (BCVA)', 'timeFrame': 'from baseline to month 12', 'description': 'To assess the effects of two therapies on visual acuity'}], 'secondaryOutcomes': [{'measure': 'Change in central subfield thickness', 'timeFrame': 'from baseline to month 12', 'description': 'optical coherence tomography (OCT) for the assessment of central macular thickness'}, {'measure': 'Fundus fluorescein angiography', 'timeFrame': 'from baseline to month 12', 'description': 'fluorescein angiography to measure area of fluorescein leakage (FLA)'}, {'measure': 'Foveal avascular zone', 'timeFrame': 'from baseline to month 12', 'description': 'Optical coherence tomography angiography (OCTA) for measurement of FAZ'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conbercept', 'Panretinal photocoagulation', 'non-proliferative diabetic retinopathy', 'diabetic macular edema'], 'conditions': ['Severe Nonproliferative Diabetic Retinopathy', 'Diabetic Retinopathy', 'Diabete Mellitus']}, 'descriptionModule': {'briefSummary': 'The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.', 'detailedDescription': 'This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nType II diabetic patients, 18 years and older, were included if the participants had:\n\n1. severe non-PDR in either eyes with/without diabetic macular edema;\n2. ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;\n3. no previous treatment (of any type) in either eye.\n\nExclusion Criteria:\n\n1. history of prior laser treatment or vitrectomy in the study eye;\n2. history of thromboembolic event - including myocardial infarction or cerebral vascular accident;\n3. major surgery within the prior 6 months or planned within the next 28 days;\n4. history of glaucoma or ocular hypertension;\n5. loss of vision as a result of other causes;\n6. history of systemic corticosteroid therapy within the last 3 months;\n7. severe systemic disease other than diabetes mellitus;\n8. known coagulation abnormalities or current use of anticoagulative medication other than aspirin\n9. any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).'}, 'identificationModule': {'nctId': 'NCT03863535', 'briefTitle': 'PRP vs PRP+IVC for Severe nPDR', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Panretinal Photocoagulation (PRP) vs PRP Combined With Intravitreous Conbercept (IVC) for Severe Nonproliferative Diabetic Retinopathy (nPDR): A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Ruijin Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal conbercept+Panretinal coagulation', 'interventionNames': ['Drug: Conbercept', 'Procedure: Panretinal coagulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panretinal coagulation', 'interventionNames': ['Procedure: Panretinal coagulation']}], 'interventions': [{'name': 'Conbercept', 'type': 'DRUG', 'description': "Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.", 'armGroupLabels': ['Intravitreal conbercept+Panretinal coagulation']}, {'name': 'Panretinal coagulation', 'type': 'PROCEDURE', 'description': "The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.", 'armGroupLabels': ['Intravitreal conbercept+Panretinal coagulation', 'Panretinal coagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Shen, PhD', 'role': 'CONTACT', 'email': 'carl_shen2005@126.com', 'phone': '+86 136-2167-7680'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xi Shen, MD', 'role': 'CONTACT', 'email': 'carl_shen2005@126.com', 'phone': '+86-021-64370045'}], 'overallOfficials': [{'name': 'Xi Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Qiong Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Municipal Science and Technology Commission', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department director of Ophthamology', 'investigatorFullName': 'Xi Shen', 'investigatorAffiliation': 'Ruijin Hospital'}}}}