Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-26 @ 1:01 PM
Study NCT ID:
NCT06653361
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2024-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-20', 'studyFirstSubmitQcDate': '2024-10-20', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCVA', 'timeFrame': '2 months', 'description': 'Best Corrected Visual Acuity'}, {'measure': 'CMT', 'timeFrame': '2 months', 'description': 'Central Macular Thickness'}, {'measure': 'MD', 'timeFrame': '2 months', 'description': 'Mean Deviation'}, {'measure': 'VFI', 'timeFrame': '2 months', 'description': 'Visual Filed Index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic retinopathy', 'Laser photocoagulation', 'Fluorescein angiography'], 'conditions': ['Proliferative Diabetic Retinopathy - High Risk']}, 'descriptionModule': {'briefSummary': 'Proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. The treatment options for proliferative diabetic retinopathy are anti-VEGF injection and retinal photocoagulation. The study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proliferative diabetic retinopathy (PDR) with neovascularization on the disc or elsewhere in the retina\n\nExclusion Criteria:\n\n* Participants with a history of previous history of:\n* retinal photocoagulation\n* vitreoretinal surgery\n* tractional retinal detachment\n* epiretinal membrane\n* vitreomacular traction\n* glaucoma\n* uveitis\n* media opacities like cataract, corneal opacity, vitreous hemorrhage\n* anti-VEGF injections in last 3 months'}, 'identificationModule': {'nctId': 'NCT06653361', 'briefTitle': 'Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hayatabad Medical Complex'}, 'officialTitle': 'Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '306/DME/KMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRP', 'description': 'Targeted Retinal Photocoagulation', 'interventionNames': ['Procedure: Green laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRP', 'description': 'Panretinal Photocoagulation', 'interventionNames': ['Procedure: Green laser']}], 'interventions': [{'name': 'Green laser', 'type': 'PROCEDURE', 'description': 'Green Laser', 'armGroupLabels': ['PRP', 'TRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Khyber Teaching Hospital Peshawar', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayatabad Medical Complex', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Khyber Teaching Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yousaf Jamal Mahsood', 'investigatorAffiliation': 'Hayatabad Medical Complex'}}}}