Clinical Trial

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

Recruiting
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Record status
This record was last updated March 6, 2024 (before its estimated September 5, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-02-14; most recent amendment 2024-03-05.
Status change: Not Yet Recruiting → Recruiting 2024-03-05
Status change: Recruiting → Not Yet Recruiting 2023-07-10
Status change: Not Yet Recruiting → Recruiting 2023-05-20
Trial Details
NCT Number NCT05728476
Lead Sponsor Tianjin Medical University Eye Hospital
Conditions Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept
Enrollment 102 participants
Start Date 2024-03-05
Primary Completion 2025-09-05 (estimated)
Study Completion 2026-09-05 (estimated)
Updated on ClinicalTrials.gov 2024-03-06