Actively Recruiting
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Led by Tianjin Medical University Eye Hospital · Updated on 2024-03-06
102
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- 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) less than 10% within 3 months
- Clear eye media allowing good quality OCT and OCT angiography images
- Treatment-naïve diabetic macular edema diagnosed clinically
- Central subfield thickness greater than 300 micrometers with intra- or subretinal fluid on spectral-domain OCT
- Best corrected visual acuity between 24 and 73 letters on ETDRS chart at randomization
- Treatment started within 12 months of DME diagnosis
- No contraindications for vitrectomy or Conbercept intravitreal injection
You will not qualify if you...
- Any previous treatment for diabetic macular edema such as anti-VEGF injections, corticosteroids, or macular photocoagulation
- Macular edema caused by other diseases like neovascular age-related macular degeneration, retinal vein occlusion, or uveitis
- Any previous intraocular surgeries except cataract surgery performed at least 3 months before study entry
- Vision loss caused by other eye diseases such as cataract, proliferative diabetic retinopathy, glaucoma, or high myopia
- Follow-up duration less than 12 months
- Severe dysfunction of heart, liver, kidney, lung, or other organs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
B
Bojie Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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