Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 12:19 AM
Study NCT ID:
NCT01737957
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2012-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Low-Fluence PRP for PDR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2012-11-23', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Regression of neovessels, change over time', 'timeFrame': 'Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks', 'description': 'Regression of neovessels observed by fluorescein angiography'}], 'primaryOutcomes': [{'measure': 'Macular thickness change', 'timeFrame': 'Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks', 'description': 'Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '16 weeks', 'description': 'Presence or absence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proliferative Diabetic retinopathy', 'Pan-retinal photocoagulation'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or type 2 diabetics\n* Proliferative diabetic retinopathy\n\nExclusion Criteria:\n\n* Previous treatment with PRP\n* Media opacities\n* Previous treatment for macular edema (LASER or intravitreal injections)\n* Recent (less than 6 months) ophthalmic surgery\n* Only eyes\n* Intra-retinal or sub-retinal fluid with foveal involvement\n* Chronic renal failure\n* History of liver or pancreatic transplant'}, 'identificationModule': {'nctId': 'NCT01737957', 'briefTitle': 'Safety and Efficacy of Low-Fluence PRP for PDR', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)', 'orgStudyIdInfo': {'id': 'APEC-LFPRP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-fluence', 'description': 'Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy', 'interventionNames': ['Device: Low-fluence PRP with 532nm green LASER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Full-fluence', 'description': 'Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy', 'interventionNames': ['Device: Full-Fluence PRP with 532nm LASER']}], 'interventions': [{'name': 'Low-fluence PRP with 532nm green LASER', 'type': 'DEVICE', 'otherNames': ['PURE-POINT LASER'], 'description': 'To administer low-fluence PRP in a single session for PDR', 'armGroupLabels': ['Low-fluence']}, {'name': 'Full-Fluence PRP with 532nm LASER', 'type': 'DEVICE', 'otherNames': ['PURE-POINT LASER'], 'description': 'To administer full-fluence PRP in two sessions for PDR', 'armGroupLabels': ['Full-fluence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación Para Evitar la Ceguera en México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Guillermo Salcedo-Villanueva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}