Comparing two treatments for diabetic macular edema
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
This study is testing whether a new eye surgery combined with a specific technique can help people with diabetic macular edema see better and avoid losing their vision compared to a common injection treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05728476 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of microinvasive pars plana vitrectomy combined with internal limiting membrane peeling versus anti-VEGF intravitreal injection in patients with treatment-naïve diabetic macular edema. The goal is to determine if early surgical intervention can reduce the treatment burden and prevent vision loss in these patients. By focusing on those who have not yet received treatment, the study aims to provide insights into long-term stabilization of diabetic retinopathy. Participants will be monitored for changes in vision and retinal health over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with treatment-naïve diabetic macular edema and specific retinal imaging findings.
Not a fit: Patients who have previously received treatment for diabetic macular edema or have macular edema from other causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for repeated injections and improve vision outcomes for patients with diabetic macular edema.
How similar studies have performed: While anti-VEGF injections are well-established, the combination of early vitrectomy and ILM peeling for treatment-naïve DME is a relatively novel approach with limited prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin medical university eye hosipital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Bojie Hu
- Email: bhu07@tum.edu.cn
- Phone: 13612130943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.