[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-maculopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-maculopathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100581458","phase-4-aflibercept-and-bevacizumab-for-diabetic-maculopathies-100581458",false,"NCT06850571","Aflibercept and Bevacizumab for Diabetic Maculopathies","Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial","Inclusion Criteria:\n\n* Patients with type 2 diabetes mellites.\n* Patients diagnosed with diabetic maculopathies, including focal and diffuse maculopathies, according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria\n* Patients with reduced or reduced vision (6\u002F9-6\u002F90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm)\n* Patients will be treated with intravitreal anti-VEGF treatment, aflibercept, or bevacizumab for three successive monthly injections.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellites\n* Patients with type 2 on insulin therapy.\n* Patients who were previously treated with intravitreal anti-VEGF within the previous three months or intravitreal corticosteroids for six months\n* Prior macular photocoagulation or photodynamic therapy, prior intraocular surgeries within three months (laser \\& surgery may cause edema)\n* Pregnant or nursing women\n* In patients with a history of thromboembolic events, systemic VEGF inhibition is likely to cause cardiovascular complications, such as arterial thromboembolic events.\n* Patients major surgery within the previous one year or planned within the next few months that may interfere with anti-VEGF treatment\n* Uncontrolled hypertension as hypertension is associated with the use of VEGF antagonists.\n* Known coagulation abnormalities or current use of anticoagulative medication other than aspirin.\n* Hemorrhagic macular infarction is reported with the use of VEGF antagonists.\n* Patients with intraocular pressure more than 25 mmHg\n* Presence of iris neovascularization\u002Fvitreous hemorrhage","ALL","40 Years",{"count":19,"type":20},102,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:\n\n* Functional changes: The visual outcomes achieved by testing visual acuity\n* Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).",[26],"Diabetic Maculopathy","RECRUITING","2025-09-18",{"date":30,"type":31},"2025-09-19","ACTUAL",{"date":33,"type":31},"2025-02-20",{"date":35,"type":20},"2025-12-01",{"name":37,"class":38},"Al-Mustansiriyah University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":39},"100589530","is-community-based-monitoring-of-diabetic-maculopathy-and-pre-proliferative-diabetic-retinopathy-safe-100589530","NCT06955611","Is Community Based Monitoring of Diabetic Maculopathy and Pre-proliferative Diabetic Retinopathy Safe?","Feasibility of an Alternative Pathway for Hospital Referrals From Diabetic Eye Screening Wales (DESW) for People Suspected With Sight-threatening Diabetic Eye Disease Diabetic Maculopathy (FARSight-DM)","FARSight-DM","Inclusion Criteria:\n\n* People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB\n\nExclusion Criteria:\n\n* \\\u003C18 years\n* People with diagnosed diabetic macular oedema\n* People with proliferative diabetic retinopathy",true,"18 Years",{"count":51,"type":20},150,[53],"NA","To assess a pathway using opticians based in their practices and a 'virtual' review by a consultant ophthalmologist, based in the hospital to assess suspected diabetic maculopathy. We want to know if this pathway works, is it acceptable to people with diabetes and what the changes might mean in terms of the outcomes for patients and NHS resources and cost?\n\nScreening by Diabetic Eye Service Wales currently involves taking and as-sessing 2-D (dimensional) digital photographs of the back of the eye (reti-na). Leakage from damaged blood vessels can cause swelling within the central part of the retina, known as maculopathy. This swelling cannot be seen on traditional 2-D images.\n\nDiagnosing maculopathy requires a 3-D camera and a technique known as Optical Coherence Tomography (OCT). OCT is not part of routine screening but, is available in the Hospital Eye Service (HES) and many optician prac-tices. If any changes are seen in the macular region of the retina on 2-D images, the patient will require an OCT scan to see if there is any in-creased thickness. Many patients do not have increased thickness and not everyone with diabetic retinopathy has maculopathy.\n\nCurrently after screening, patients who have macular changes that suggest possible maculopathy are referred to the HES for OCT imaging. Many of these patients will not have increased thickness and the appointment could have been better used to see a different patient with increased thickness that requires treatment.\n\nThe new pathway that will be investigated in this study involves trained opticians in practices that have an OCT camera taking the required 3-D images and carrying out the initial examination. The images and patient record will then be reviewed by an ophthalmologist working virtually, to decide the management plan. If this pathway is safe and acceptable to people with diabetes, it would reduce the pressure on HES clinics. It will also develop new skills for opticians and allow people to be seen closer to their home, reducing the stress that referrals can create and lowering the carbon footprint of the service.",[56,57,26],"Diabetes Mellitus","Diabetic Retinopathy",[59,60,61,62],"Feasibility","Randomised Control Trial","OCT","Screening","2025-04-24",{"date":65,"type":31},"2025-05-02",{"date":67,"type":31},"2024-11-20",{"date":69,"type":20},"2025-09",{"name":71,"class":38},"Hywel Dda Health Board",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":39},"100416223","evaluation-of-neoretina-artificial-intelligence-algorithm-for-the-screening-of-diabetic-retinopathy-at-the-chum-100416223","NCT04699864","Evaluation of NeoRetina Artificial Intelligence Algorithm for the Screening of Diabetic Retinopathy at the CHUM","The Use of Artificial Intelligence in the Early Detection and the Follow-Up of Diabetic Retinopathy of Diabetic Patients Followed at the CHUM: Evaluation of NeoRetina Automated Algorithm (DIAGNOS Inc.)","DR-NeoRetina","Inclusion Criteria:\n\n1. Patients of 18 years old and older;\n2. Ability to provide informed consent;\n3. Diagnostic for diabetes : 3a) Type 1 diabetes of a lest 5 years of evolution; or 3b) Type 2 diabetes;\n4. Diabetic patient followed and refered by a physician of the Centre hospitalier de l'Université de Montréal (CHUM) : 4a) followed by an endocrinologist of the CHUM; or 4b) hospitalized at the CHUM; or 4c) on the waiting list of the Ophthalmology Clinic of the CHUM for the evaluation of DR.\n\nExclusion Criteria:\n\n1. Patients less than 18 years old;\n2. Inability to provide informed consent;\n3. Patient who already had a treatment (surgery, laser, injection, etc.) for any retinal condition : Age-related macular degeneration (AMD), retinal vascular occlusion (RVO); etc.",{"count":81,"type":20},630,[53],"This prospective study aims to validate if NeoRetina, an artificial intelligence algorithm developped by DIAGNOS Inc. and trained to automatically detect the presence of diabetic retinopathy (DR) by the analysis of macula centered eye fundus photographies, can detect this disease and grade its severity.",[57,85,26],"Diabetic Macular Edema",[87,88,89,90,91,92,93,94,95,56,96],"Diabetes","Type 1 Diabetes","Type 2 Diabetes","Diabetic Retinopathy (DR)","Diabetic Macular Edema (DME)","Ophthalmological Evaluation","Screening of Diabetic Retinopathy","Eye Disease","Eye Complications of Diabetes","Artificial Intelligence","2024-09-16",{"date":99,"type":31},"2024-09-19",{"date":101,"type":31},"2024-06-10",{"date":103,"type":20},"2026-12",{"name":105,"class":38},"Centre hospitalier de l'Université de Montréal (CHUM)"]