[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636603":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":31,"collaborators":33,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":30,"enrollmentInfo":46,"targetDuration":30,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":30,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":30},{"fullName":5,"class":6},"Jaeb Center for Health Research","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Mild center-involved diabetic macular edema","ACTIVE_COMPARATOR","Eyes with optical coherence tomography central subfield thickness \\\u003C75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men",[13],"Drug: Anti-Vascular Endothelial Growth Factor",{"label":15,"type":10,"description":16,"interventionNames":17},"Moderate Center-involved diabetic macular edema","Eyes with OCT central subfield thickness 75 to \\\u003C175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Severe Center-involved diabetic macular edema","Severe CI-DME: Eyes with OCT central subfield thickness \\>=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Anti-Vascular Endothelial Growth Factor","All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20\u002F20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).",[9,15,19],[29],"Anti-VEGF",null,{"type":32,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[34],{"name":35,"class":36},"National Eye Institute (NEI)","NIH","100636603","phase-4-longitudinal-study-of-retinal-function-in-eyes-treated-for-diabetic-macular-edema-with-anti-vegf-agents-100636603",false,"NCT07567833","Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents","AS","Key inclusion criteria:\n\n* Age ≥18 years\n* Diagnosed with Type 1 or Type 2 diabetes\n* Best corrected visual acuity 20\u002F320 or better (Snellen) (≥24 ETDRS letters)\n* At least 1 eye with CI-DME requiring treatment\n* Able and willing to provide informed consent.\n\nKey exclusion criteria:\n\n* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.\n* Previous treatment of any kind for diabetic retinopathy or DME\n* Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)\n* History of rhegmatogenous retinal detachment or macular hole\n* History of vitrectomy\n* Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months","ALL","18 Years",{"count":47,"type":48},100,"ESTIMATED","INTERVENTIONAL",[51],"PHASE4","A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.",[54],"Diabetic Retinal Disease","NOT_YET_RECRUITING","2026-04-28",{"date":58,"type":59},"2026-05-05","ACTUAL",{"date":61,"type":48},"2026-05-01",{"date":63,"type":48},"2033-05",{"name":5,"class":6}]