Age-Related Macular Degeneration (ARMD) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
Other Locations
China
Tianjin medical university eye hosipital
RECRUITING
Tianjin
Contact Information
Primary
Bojie Hu
bhu07@tum.edu.cn
13612130943
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2026-09-05
Participants
Target number of participants: 102
Treatments
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.
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.
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Vitrectomy
Age-Related Macular Degeneration (ARMD)
Diabetic Retinopathy
Diabetic Macular Edema (DME)
Sponsors
Leads: Tianjin Medical University Eye Hospital

This content was sourced from clinicaltrials.gov

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