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

NARecruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

March 5, 2024

Primary Completion Date

September 5, 2025

Study Completion Date

September 5, 2026

Conditions
Diabetic Macular EdemaPars Plana VitrectomyConbercept
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

Tianjin medical university eye hosipital, Tianjin

All Listed Sponsors
lead

Tianjin Medical University Eye Hospital

OTHER