drugset / Trial / NCT05728476

Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema

NCT05728476

Recruiting 102 enrolled Tianjin Medical University Eye Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Diabetic macular edema (DME) is the main cause of vision loss in patients with diabetes. At present, anti-vascular endothelial growth factor (VEGF) intravitreal injection is the first-line therapy for DME, nevertheless, some patients do not respond well to anti-VEGF agents and often require multiple injections, which increases the psychological and economic burden of patients. Microinvasive pars plana vitrectomy (PPV) has been proven to be safe and effective for refractory DME. However, there are few studies on treatment-naïve DME. The purpose of this study is to explore whether early PPV combined with internal limiting membrane (ILM) peeling can reduce the treatment burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.

Timeline

Start
2024-03-05
Primary completion
2025-09-05
Completion
2026-09-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Conbercept Protein / enzyme biologic 0.5 mg Intravitreal