NCT05728476

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Tianjin Medical University Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema
• Pars Plana Vitrectomy
• Conbercept

Interventions

Type	Name	Description
PROCEDURE	Vitrectomy combined with ILM peeling	Standard 25-gauge PPV will be performed by an experienced surgeon under retrobulbar anesthesia. After clearing the central vitreous, a complete posterior vitreous detachment (PVD) will be achieved with aspiration to remove the tightly attached posterior hyaloid. The vitreous will be removed by a high-speed vitrectomy surgical system (Constellation Vision System, Alcon Laboratories, Fort Worth, Texas, USA). The ILM stained with indocyanine green (ICG) will be peeled up to the vascular arcades. In case of need, panretinal photocoagulation (PRP) can be performed during surgery. The vitreous cavity will be filled with balanced salt solution (BSS) at the end of the procedure.
DRUG	Conbercept intravitreal injection	Patients will receive three monthly intravitreal injections of 0.5 mg Conbercept (Chengdu Kanghong Biotech Co.) with a 30-gauge syringe needle approximately 3.5-4 mm posterior to the corneal limbus under topical anesthesia.

Timeline

• Start date: 2024-03-05
• Primary completion: 2025-09-05
• Completion: 2026-09-05
• First posted: 2023-02-15
• Last updated: 2024-03-06

Locations

1 site across 1 country: China