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Compares treatment options for Diabetic Macular Edema
Official title Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
ClinicalTrials.gov ID: NCT05728476
What this study is testing
What is Conbercept intravitreal injection?
Conbercept intravitreal injection is an investigational medicine, given as a monthly treatment applied to the skin, being studied as a potential treatment for diabetic macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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)
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.