Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vitrectomy group 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. |
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.
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| Active Comparator: Anti-VEGF group 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. |
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.
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Outcome Measures
Primary Outcome Measures
- Best corrected visual acuity change (BCVA) [1, 3, 6, 12 month postoperatively]
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
- Central subfield thickness (CST) change [1, 3, 6, 12 month postoperatively]
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Secondary Outcome Measures
- The stage of diabetic retinopathy (DR) [12 month postoperatively]
The grading and classification of DR will follow the International Clinical Diabetic Retinopathy and Diabetic Macular Oedema Disease Severity Scales. Ultra-wide field fundus photography will help investigators grade diabetic retinopathy.
- Cost-effectiveness analysis [12 month postoperatively]
The incremental cost-effectiveness ratio (ICER) is used as the evaluation index in cost-effectiveness analysis. The average cost of the two groups of treatments is taken as willingness to pay (WTP). If ICER is less than WTP, the treatment scheme is cost-effective.
- Vision-related quality of life questionnaire [6, 12 month postoperatively]
The National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) will be used to evaluate the vision-related quality of life. Scores range from 0 to 100, and lower scores indicate a poorer quality of life.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years of age
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Patients and their families fully understand the research and sign the informed consent form
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Diagnosed with type 1 or 2 diabetes mellitus
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Hemoglobin A1c (HbA1c) of less than 10% within 3 months
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Clear media for adequate OCT and optical coherence tomography angiography (OCTA) images
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Treatment-naïve DME diagnosed clinically
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Central subfield thickness (CST) of >300μm and intra- or subretinal fluid seen on (spectral-domain) SD-OCT
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Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA between 24 and 73 letters on the day of randomization
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Treatment within 12 months of DME diagnosis
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No contraindication of vitrectomy or conbercept intravitreal injection
Exclusion Criteria:
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Any previous DME treatment (i.e. anti-VEGF injections, intraocular corticosteroids, macular photocoagulation)
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Macular edema caused by other disease (i.e. neovascular age-related macular degeneration, retinal vein occlusion, uveitis)
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Any previous intraocular surgeries (cataract surgery performed at least 3 months before study entry will not be exclusionary)
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Vision loss caused by other ocular disease (i.e. cataract, proliferative diabetic retinopathy, glaucoma, high myopia)
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A follow-up duration of less than 12 months
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Severe dysfunction of the heart, liver, kidney, lung and other organs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin medical university eye hosipital | Tianjin | Tianjin | China |
Sponsors and Collaborators
- Tianjin Medical University Eye Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TianjinMUEHhbj111