Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:48 AM
Study NCT ID:
NCT06821633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months', 'timeFrame': 'From enrollment to reexamination at 0,3,6,9, and 12 months'}], 'secondaryOutcomes': [{'measure': 'The number of microaneurysms, intraretinal microvascular abnormalities (IRMA) in both groups of eyes at 0, 3, 6, 9, and 12 months', 'timeFrame': 'From enrollment to reexamination at 0,3,6,9, and 12 months'}, {'measure': 'The number of neovascularization (NV) in both groups of eyes at 0, 3, 6, 9, and 12 months', 'timeFrame': 'From enrollment to reexamination at 0,3,6,9, and 12 months'}, {'measure': 'Area of foveal avascular zone (FAZ) at 0, 3, 6, 9, and 12 months in two groups of eyes', 'timeFrame': 'From enrollment to reexamination at 0,3,6,9, and 12 months'}, {'measure': 'DR grading at 0, 3, 6, 9, and 12 months in two groups of eyes', 'timeFrame': 'From enrollment to reexamination at 0,3,6,9, and 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. From February 2025 to August 2026, 30 diabetic patients attending the Ophthalmology Department of Sichuan Provincial People's Hospital will be enrolled. Using a simple randomization method, one eye of each patient will be assigned to the intervention group, while the contralateral eye will serve as the control, resulting in 30 eyes in each group. The intervention group will undergo OCTA-guided selective photocoagulation, specifically using a grid pattern (3x3) of spot laser applied once to the NP area, extending one spot diameter beyond the NP boundary. Each session will last 10-20 minutes. The control group will receive no treatment. The study will compare changes in NP area, DR grading progression, and control of other DR lesions at 3, 6, 9, and 12 months between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Type 1 or Type 2 diabetes mellitus\n* Clinical dilated fundus examination and Optos imaging within 7 fields showing diabetic retinopathy (DR) lesions no more severe than severe non-proliferative diabetic retinopathy (NPDR)\n* Optical coherence tomography angiography (OCTA) demonstrating non-perfusion (NP) areas greater than 1 disc diameter (PD) in both eyes\n* Diabetic retinopathy in both eyes at the same stage, with the total NP area within the observed range of OCTA being comparable (difference less than 5 PD)\n* Absence of other ocular diseases that could lead to the formation of retinal microaneurysms\n* Absence of other ocular diseases that could lead to the formation of retinal non-perfusion areas\n* No diabetic macular edema involving the fovea\n* No history of retinal laser treatment\n* No history of intravitreal injection therapy within the past 3 months\n* No history of ocular surgery other than cataract surgery\n* Ability to cooperate with all examinations and provide informed consent\n\nExclusion Criteria:\n\n* Optical media opacity affecting OCTA imaging\n* Patients with difficulties in cooperating with laser treatment\n* Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases\n* Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces\n* Patients requiring early PRP (conditions include: combined DME, planned cataract surgery, pregnancy planning, early PDR, poor follow-up compliance, severe vision loss in the other eye, poor glycemic control, poor renal function, or type 1 diabetes)\n* FFA showing NP greater than 10 PD within the ETDRS area or a total NP area greater than 75 PD, or an ischemia index greater than 35%'}, 'identificationModule': {'nctId': 'NCT06821633', 'briefTitle': 'Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients', 'organization': {'class': 'OTHER', 'fullName': "Sichuan Provincial People's Hospital"}, 'officialTitle': 'Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients', 'orgStudyIdInfo': {'id': '2024-KY740-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital', 'description': "The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes.", 'interventionNames': ['Procedure: Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)']}, {'type': 'NO_INTERVENTION', 'label': 'Eyes with NPDR that were diagnosed at our hospital', 'description': 'Perform the same examination but administer no treatment'}], 'interventions': [{'name': 'Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)', 'type': 'PROCEDURE', 'description': "The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes.", 'armGroupLabels': ['Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610014', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Jie Li, doctor', 'role': 'CONTACT', 'email': 'lijieyk@med.uestc.edu.cn', 'phone': '+86 13908094675'}], 'facility': "Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Jie Li, doctor', 'role': 'CONTACT', 'email': 'lijieyk@med.uestc.edu.cn', 'phone': '+86 139 0809 4675'}]}, 'ipdSharingStatementModule': {'url': 'http://pan.baidu.com', 'infoTypes': ['CSR'], 'timeFrame': '2025 and forever', 'ipdSharing': 'YES', 'description': '2030, via https://pan.baidu.com', 'accessCriteria': 'via https://pan.baidu.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jie Li', 'investigatorAffiliation': "Sichuan Provincial People's Hospital"}}}}