Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT06841250
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-24
First Post:
2025-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Changes in OCT Biomarkers After the First Intravitreal Anti-VEGF Injection in Treatment-naïve DME
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'one month', 'description': 'Visual acuity assessment pre and post injection will be recorded'}, {'measure': 'Central subfield thickness', 'timeFrame': 'one month', 'description': 'Central subfield thickness assessment pre and post injection will be recorded'}, {'measure': 'Intraretinal cystoid spaces', 'timeFrame': 'one month', 'description': 'Intraretinal cystoid space location, size and bridging will be recorded pre and post injection'}, {'measure': 'Subfoveal neuroretinal detatchment', 'timeFrame': 'one month', 'description': 'Presence and extent of Subfoveal neuroretinal detatchment assessed pre and post injection will be recorded'}, {'measure': 'Hyperreflective foci', 'timeFrame': 'one month', 'description': 'number and locatio of Hyperreflective foci assessed pre and post injection will be recorded'}, {'measure': 'Outer retinal layer integrity', 'timeFrame': 'one month', 'description': 'Outer retinal layer integrity assessment pre and post injection will be recorded'}, {'measure': 'Disorganised inner retinal layers', 'timeFrame': 'one month', 'description': 'Disorganised inner retinal layers assessment pre and post injection will be recorded'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early OCT Biomarker Changes in Response to Anti-VEGF']}, 'descriptionModule': {'briefSummary': 'A retrospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.', 'detailedDescription': "Aim of the work To evaluate early changes in OCT biomarkers and visual acuity in treatment-naïve patients with diabetic macular oedema after the first intravitreal antiVEGF injection.\n\nPatients and methods Study Design A retrospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.\n\nPatients This study will include 50 eyes with center-involving DME (CI-DME) of patients who received their 1st AntiVEGF injection as a routine treatment in the Department of Ophthalmology, Sohag University Hospital.\n\nInclusion Criteria\n\n1. Diabetic patients with center-involving DME (CI-DME) who are treatment-naïve.\n2. Central macular thickness (CMT) of 300 microns or more will be accepted as CI-DME.\n\nExclusion Criteria\n\n1. Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).\n2. Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).\n3. Patients who have had previous intravitreal injections or Laser treatment.\n4. Patients who underwent previous vitreoretinal surgeries.\n5. Patients with recent history of undergoing cataract surgery.\n6. Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis). 4\n\nMethods\n\nWe will analyze the medical records of the study participants before and after injection and the collected data will include:\n\nA. History:\n\nPatient age, gender, duration and treatment of diabetes mellitus, visual impairment history, ocular/systemic comorbidities, topical/systemic drug intake, previous ocular/systemic interventional procedures or surgery.\n\nB. Medical Examination and Laboratory investigations:\n\nBlood Pressure, Lipid profile, HbA1c will be measured.\n\nC. Full ophthalmological examination:\n\nData recorded from the preoperative ophthalmic examination of the studied eye, which includes:\n\n1. Best corrected visual acuity (BCVA): Snellen visual acuities will be presented as Snellen decimal notation.\n2. Intraocular pressure (IOP) measured by I-Care rebound tonometer.\n3. Slit lamp examination of the anterior segment and angle of the anterior chamber.\n4. Fundus examination by indirect ophthalmoscope and slit lamp biomicroscopy with documentation of the stage of diabetic retinopathy.\n\nD. OCT imaging:\n\nOCT images and data will be collected and analysed from the electronic medical reports for all patients at 3 points:\n\n1. Before injection (within one week before the procedure).\n2. Two weeks after injection.\n3. One month after injection. 5\n\nThe collected OCT data will include the following biomarkers:\n\n* Determining the type of DME (diffuse, cystoid, serous retinal detachment).\n* Mean central subfield thickness (CST).\n* Presence, location and height of macular Intraretinal cystoid spaces (ICS).\n* Presence of Subfoveal neuroretinal detachment (SND) and height of serous macular detachment.\n* The presence and size, and localization of hyperreflective foci (HF) within the retina.\n* The disorganisation of the inner retinal layers (DRIL).\n* The presence of vitreomacular traction.\n* The integrity of the outer retinal layers, (ellipsoid zone (EZ) and external limiting membrane (ELM)).\n\nE. Theinjectionprocedure:\n\nThe surgical notes will be reviewed from the patient's files to report the injection procedure, preparations and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic macular Oedema patients who are treatment naïve.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients with centre-involving DME (CI-DME) who are treatment-naïve.\n* Central macular thickness (CMT) of 300 microns or more will be accepted as DME.\n\nExclusion Criteria:\n\n* Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).\n* Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).\n* Patients who have had previous intravitreal injections or Laser treatment.\n* Patients who underwent previous vitreoretinal surgeries.\n* Patients with recent history of undergoing cataract surgery.\n* Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis).'}, 'identificationModule': {'nctId': 'NCT06841250', 'briefTitle': 'Early Changes in OCT Biomarkers After the First Intravitreal Anti-VEGF Injection in Treatment-naïve DME', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Early Changes in OCT Biomarkers After the First Intravitreal Anti-VEGF Injection in Treatment-naïve DME', 'orgStudyIdInfo': {'id': 'Soh-Med--25-1-08MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DME patients who are treatment-naïve', 'description': 'The collected OCT data will include the following biomarkers:\n\n* Determining the type of DME (diffuse, cystoid, serous retinal detachment).\n* Mean central subfield thickness (CST).\n* Presence, location and height of macular Intraretinal cystoid spaces (ICS).\n* Presence of Subfoveal neuroretinal detachment (SND) and height of serous macular detachment.\n* The presence and size, and localization of hyperreflective foci (HF) within the retina.\n* The disorganisation of the inner retinal layers (DRIL).\n* The presence of vitreomacular traction.\n* The integrity of the outer retinal layers, (ellipsoid zone (EZ) and external limiting membrane (ELM)).', 'interventionNames': ['Procedure: intravitreal injection of anti-VEGF']}], 'interventions': [{'name': 'intravitreal injection of anti-VEGF', 'type': 'PROCEDURE', 'description': 'Ranibizumab is injected into the vitreous under aseptic conditions as part of routine DME treatment', 'armGroupLabels': ['DME patients who are treatment-naïve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nada Essam Ahmed', 'investigatorFullName': 'Nada Essam Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}