Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 7:00 PM
Study NCT ID:
NCT05861466
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-24', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the acute change in angiographic parameters', 'timeFrame': '1 day', 'description': 'OCTA of macula and peripapillary region with documentation of vessel density'}], 'secondaryOutcomes': [{'measure': 'the acute change in intra-ocular pressure', 'timeFrame': '1 day', 'description': 'Goldman applanation tonometry for evaluation of IOP'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .\n\nThe main question\\[s\\]it aims to answer are:\n\n•\\[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?\\] •\\[is there any effect of Prior Anterior Chamber Paracentesis?\\] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)\\& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . \\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetes mellitus type II.\n* Patients with visual acuity \\> 0.1, able to fixate and with clear visual media.\n* Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.\n\nExclusion Criteria:\n\n* Age under 40 years.\n* Poorly controlled diabetics (HbA1C greater than 9.0%)\n* Proliferative diabetic retinopathy.\n* OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)\n* Neovascular AMD in the study eye.\n* History of glaucoma.\n* Tilted disc and optic disc anomalies.\n* One-eyed patients.\n* Usage of systemic or topical corticosteroids.\n* Patients with a history of intraocular surgery other than cataract surgery.\n* Systemc diseases rather than hypertension and diabetes mellitus.\n* Corneal opacities that might hinder acquisition of good quality OCT images.'}, 'identificationModule': {'nctId': 'NCT05861466', 'briefTitle': 'Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]', 'orgStudyIdInfo': {'id': 'MD 1692022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.', 'interventionNames': ['Drug: intra-vitreal injection of Ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.', 'interventionNames': ['Drug: intra-vitreal injection of Ranibizumab', 'Procedure: anterior chamber paracentesis']}], 'interventions': [{'name': 'intra-vitreal injection of Ranibizumab', 'type': 'DRUG', 'description': 'The intravitreal injection will be performed with ranibizumab (0.5 mg/0.05 mL through a 27-gauge needle that will be inserted into the sclera 3.5 mm from the corneal limbus in pseudophakic patients, and 4 mm in phakic patients.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'anterior chamber paracentesis', 'type': 'PROCEDURE', 'description': 'A 27-gauge needle on a 1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of ophthalmology', 'investigatorFullName': 'Amr Sanad', 'investigatorAffiliation': 'Ain Shams University'}}}}