Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT05716932
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2023-01-29', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in best corrected visual acuity (BCVA)', 'timeFrame': '6 months', 'description': 'NCVA change between baseline and final follow up at 6 months'}], 'secondaryOutcomes': [{'measure': 'change in central macular thickness (CMT)', 'timeFrame': '(Time frame: 6 months)', 'description': 'between baseline and final follow up at 6 months'}, {'measure': 'incidence of complications due to laser or intravitreal injection.', 'timeFrame': '6 months', 'description': 'presence or absence of complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Artery Macroaneurysm']}, 'descriptionModule': {'briefSummary': 'Treatment options for Retinal artery Macroaneurysm (RAM) include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. \\[3-5\\] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. \\[3-15\\] YAG hyaloidotomy is used for fresh premacular hemorrhage. \\[16\\] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. \\[17\\]\n\nHowever, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. \\[3-17\\]\n\n.', 'detailedDescription': 'Retinal arterial macroaneurysm (RAM) is an acquired localized arterial dilatation, which often occurs at second or third branches of the central retinal artery. Mostly, elderly hypertensive females above 60 years are affected. One in 4500 people over the age of 40 years is liable to develop a RAM. It may be associated with retinal vein occlusion. \\[1\\]\n\nThe natural history of a RAM can be divided into a growing phase, followed by gradual fibrosis and/ or thrombosis (closure), and then involution. A growing macroaneurysm may leak, resulting in intraretinal exudation and macular edema. It may rupture producing subretinal, intraretinal, preretinal, and / or vitreous hemorrhage. Approximately 8%-25% of RAMs undergo spontaneous involution without treatment. However, treatment is required for leaking macroaneurysms to prevent macular structural damage. \\[2,3\\]\n\nTreatment options for RAM include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. \\[3-5\\] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. \\[3-15\\] YAG hyaloidotomy is used for fresh premacular hemorrhage. \\[16\\] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. \\[17\\]\n\nHowever, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. \\[3-17\\]\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective review of records of eyes with RAM; treated between February 2012 and November 2020; will be done, to collect and analyze the following data: Treatment details, features of RAM, associated retinal disease, best-corrected visual acuity (BCVA), central macular thickness (CMT), signs of RAM involution, and possible complications', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* We will enroll cases of RAM that had been treated by Direct and perilesional focal laser, followed by a single intravitreal ranibizumab injection a few days later, and had been followed up for at least 6 months\n\nExclusion Criteria:\n\n* • RAM treated by a single approach (laser or intravitreal injections),\n\n * RAM treated by other anti-VEGF injections (not ranibizumab),\n * RAM with a shorter than 6 months of follow-up after combined laser and ranibizumab'}, 'identificationModule': {'nctId': 'NCT05716932', 'acronym': 'RAM', 'briefTitle': 'Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.', 'organization': {'class': 'OTHER', 'fullName': 'Dar El Oyoun Hospital'}, 'officialTitle': 'Validity of Focal Laser Photocoagulation Followed by a Single Intravitreal Ranibizumab Injection for Retinal Artery Macroaneurysm.', 'orgStudyIdInfo': {'id': 'N-122-2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dual focal laser and intravitreal Ranibizumab injection', 'type': 'PROCEDURE', 'otherNames': ['DFL and IVR'], 'description': 'Direct and perilesional focal laser followed by a single intravitreal 0.5 mg ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA, USA) injection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr alainy faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dar El Oyoun Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Wael Ewais', 'investigatorFullName': 'Wael Ahmed Ewais', 'investigatorAffiliation': 'Dar El Oyoun Hospital'}}}}