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

NCT05728476 | Recruiting

• 1 other identifier: TianjinMUEHhbj111
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema; Pars Plana Vitrectomy; Conbercept

Outcome Measures

Primary Outcomes (2)

• Best corrected visual acuity change (BCVA)

  Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart

  1, 3, 6, 12 month postoperatively

• Central subfield thickness (CST) change

  Three-dimensional spectral domain optical coherence tomography (SD-OCT)

  1, 3, 6, 12 month postoperatively

Secondary Outcomes (7)

• The stage of diabetic retinopathy (DR)

  12 month postoperatively

• Cost-effectiveness analysis

  12 month postoperatively

• Vision-related quality of life questionnaire

  6, 12 month postoperatively

• Biomarkers of optical coherence tomography (OCT)

  1, 3, 6, 12 month postoperatively

• Biomarkers of OCT angiography (OCTA)

  1, 3, 6, 12 month postoperatively

Study Arms (2)

Vitrectomy group

EXPERIMENTAL

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

Anti-VEGF group

ACTIVE COMPARATOR

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

Interventions

Vitrectomy combined with ILM peeling PROCEDURE

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.

Vitrectomy group

Conbercept intravitreal injection DRUG

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.

Anti-VEGF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

KH902 fusion protein

Central Study Contacts

Bojie Hu

CONTACT

13612130943; bhu07@tum.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 15, 2023
• Study Start: March 5, 2024
• Primary Completion: September 5, 2025
• Study Completion (Estimated): September 5, 2026
• Last Updated: March 6, 2024

Record last verified: 2023-10

Locations

CN (1)