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Recruiting NCT05728476

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

No phase Interventional Diabetic Macular Edema Pars Plana Vitrectomy Conbercept

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitrectomy combined with ILM peeling, Conbercept intravitreal injection.
Who it may be relevant to
Registry conditions: Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Best corrected visual acuity change (BCVA) [Time frame: 1, 3, 6, 12 month postoperatively]
  • Central subfield thickness (CST) change [Time frame: 1, 3, 6, 12 month postoperatively]
Secondary outcome measures (7)
  • The stage of diabetic retinopathy (DR) [Time frame: 12 month postoperatively]
  • Cost-effectiveness analysis [Time frame: 12 month postoperatively]
  • Vision-related quality of life questionnaire [Time frame: 6, 12 month postoperatively]
  • Biomarkers of optical coherence tomography (OCT) [Time frame: 1, 3, 6, 12 month postoperatively]
  • Biomarkers of OCT angiography (OCTA) [Time frame: 1, 3, 6, 12 month postoperatively]
  • Occurrence rates of re-treatment [Time frame: 12 months postoperatively]
  • Occurrence rates of adverse events [Time frame: 12 months postoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin medical university eye hosipital — Tianjin

Publications

  • Guo H, Li W, Nie Z, Zhang X, Jiao M, Bai S, Duan N, Li X, Hu B. Microinvasive pars plana vitrectomy combined with internal limiting membrane peeling versus anti-VEGF intravitreal injection for treatment-naive diabetic macular edema (VVV-DME study): study protocol for a randomized controlled trial. Trials. 2023 Oct 24;24(1):685. doi: 10.1186/s13063-023-07735-w. PMID 37875997

Identifiers

NCT: NCT05728476 · TianjinMUEHhbj111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗