Back to resultsMicroinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vitrectomy combined with ILM peeling
Conbercept intravitreal injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
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
Sites / Locations
- Tianjin medical university eye hosipital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vitrectomy group
Anti-VEGF group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Best corrected visual acuity change (BCVA)
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Central subfield thickness (CST) change
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Secondary Outcome Measures
The stage of diabetic retinopathy (DR)
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
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
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.
Biomarkers of optical coherence tomography (OCT)
Scanning was centred on the macular fovea with a scan length of 6 mm. The resolution was 5 μm, the scan depth was 4 mm, and the scan mode was horizontal linear scanning of 512×128.
Biomarkers of OCT angiography (OCTA)
The scanning area, centred on the fovea, was captured in 3×3 mm sections with a resolution of 304×304 pixels.
Occurrence rates of re-treatment
Pro re nata conbercept treatment will be performed if the following criteria are met: (1) existence of recent or persisting cystoid retinal lesions; (2) a decrease of no less than 5 ETDRS letters in BCVA; and (3) an increase of 50 μm or more in CST compared with the best value previously achieved.
Occurrence rates of adverse events
Ocular hypertension, progression of cataract, corneal abrasion, retinal injury, hyphaemia, uveitis or inflammatory reaction, and endophthalmitis.
Full Information
NCT ID
NCT05728476
First Posted
February 2, 2023
Last Updated
October 4, 2023
Sponsor
Tianjin Medical University Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05728476
Brief Title
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Official Title
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitrectomy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Anti-VEGF group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy combined with ILM peeling
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Conbercept intravitreal injection
Intervention Description
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 Measure Information:
Title
Best corrected visual acuity change (BCVA)
Description
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Time Frame
1, 3, 6, 12 month postoperatively
Title
Central subfield thickness (CST) change
Description
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Time Frame
1, 3, 6, 12 month postoperatively
Secondary Outcome Measure Information:
Title
The stage of diabetic retinopathy (DR)
Description
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.
Time Frame
12 month postoperatively
Title
Cost-effectiveness analysis
Description
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.
Time Frame
12 month postoperatively
Title
Vision-related quality of life questionnaire
Description
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.
Time Frame
6, 12 month postoperatively
Title
Biomarkers of optical coherence tomography (OCT)
Description
Scanning was centred on the macular fovea with a scan length of 6 mm. The resolution was 5 μm, the scan depth was 4 mm, and the scan mode was horizontal linear scanning of 512×128.
Time Frame
1, 3, 6, 12 month postoperatively
Title
Biomarkers of OCT angiography (OCTA)
Description
The scanning area, centred on the fovea, was captured in 3×3 mm sections with a resolution of 304×304 pixels.
Time Frame
1, 3, 6, 12 month postoperatively
Title
Occurrence rates of re-treatment
Description
Pro re nata conbercept treatment will be performed if the following criteria are met: (1) existence of recent or persisting cystoid retinal lesions; (2) a decrease of no less than 5 ETDRS letters in BCVA; and (3) an increase of 50 μm or more in CST compared with the best value previously achieved.
Time Frame
12 months postoperatively
Title
Occurrence rates of adverse events
Description
Ocular hypertension, progression of cataract, corneal abrasion, retinal injury, hyphaemia, uveitis or inflammatory reaction, and endophthalmitis.
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bojie Hu
Phone
13612130943
Email
bhu07@tum.edu.cn
Facility Information:
Facility Name
Tianjin medical university eye hosipital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojie Hu
Phone
13612130943
Email
bhu07@tmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
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