NCT05728476 Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
| NCT ID | NCT05728476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Medical University Eye Hospital |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2025-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2024-03-05 with a primary completion date of 2025-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * ≥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 * Clear media for adequate OCT and optical coherence tomography angiography (OCTA) images * Treatment-naïve DME diagnosed clinically * Central subfield thickness (CST) of \>300μm and intra- or subretinal fluid seen on (spectral-domain) SD-OCT * Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA between 24 and 73 letters on the day of randomization * Treatment within 12 months of DME diagnosis * No contraindication of vitrectomy or conbercept intravitreal injection Exclusion Criteria: * 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) * A follow-up duration of less than 12 months * Severe dysfunction of the heart, liver, kidney, lung and other organs
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05728476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05728476 currently recruiting?
Yes, NCT05728476 is actively recruiting participants. Contact the research team at bhu07@tum.edu.cn for enrollment information.
Where is the NCT05728476 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05728476 clinical trial?
NCT05728476 is sponsored by Tianjin Medical University Eye Hospital. The trial plans to enroll 102 participants.