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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Eye Hospital

About this trial

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.

Eligibility criteria

Qualifiers

≥18 years of age

Patients and their families fully understand the research and sign the informed consent form

Diagnosed with type 1 or 2 diabetes mellitus

Hemoglobin A1c (HbA1c) of less than 10% within 3 months

Disqualifiers

Any previous DME treatment (i.e. anti-VEGF injections, intraocular corticosteroids, macular photocoagulation)

Macular edema caused by other disease (i.e. neovascular age-related macular degeneration, retinal vein occlusion, uveitis)

Any previous intraocular surgeries (cataract surgery performed at least 3 months before study entry will not be exclusionary)

Vision loss caused by other ocular disease (i.e. cataract, proliferative diabetic retinopathy, glaucoma, high myopia)

Trial design

Treatments tested in this trial

  • Vitrectomy combined with ILM peeling
  • Conbercept intravitreal injection

Treatment groups

102 Participants
are divided into 2 treatment groups