Diabetic Macular EdemaNCT05728476
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
A study testing Vitrectomy combined with ILM peeling and Conbercept intravitreal injection in people with Diabetic Macular Edema and Pars Plana Vitrectomy, run by Tianjin Medical University Eye Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept
- What is being tested?
- Vitrectomy combined with ILM peeling and Conbercept intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2024to 5 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality
Bojie Hu, 13612130943, bhu07@tmu.edu.cn
About this study
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
- Being tested
- Vitrectomy combined with ILM peeling, Conbercept intravitreal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy combined with ILM peelingProcedure or surgery
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.
Conbercept intravitreal injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Conbercept intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity change (BCVA)
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Measured: 1, 3, 6, 12 month postoperatively
Central subfield thickness (CST) change
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Measured: 1, 3, 6, 12 month postoperatively
Secondary outcomes (7)
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.
Measured: 12 month postoperatively
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.
Measured: 12 month postoperatively
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.
Measured: 6, 12 month postoperatively
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.
Measured: 1, 3, 6, 12 month postoperatively
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.
Measured: 1, 3, 6, 12 month postoperatively
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.
Measured: 12 months postoperatively
Occurrence rates of adverse events
Ocular hypertension, progression of cataract, corneal abrasion, retinal injury, hyphaemia, uveitis or inflammatory reaction, and endophthalmitis.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start5 Mar 2024
- Primary completion5 Sep 2025 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojie Hu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728476
- Sponsor's protocol ID
- TianjinMUEHhbj111
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37875997
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05728476
- Acronym / sponsor ID
- TianjinMUEHhbj111
- Conditions
- Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 5 Sep 2025 (estimated)
- Study completion
- 5 Sep 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy group | Experimental | Procedure: Vitrectomy combined with ILM peelingStandard 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. |
| Anti-VEGF group | Active comparator | Drug: Conbercept intravitreal injectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitrectomy combined with ILM peelingStandard 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 or surgery | Vitrectomy group |
| Conbercept intravitreal injectionPatients 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 | Anti-VEGF group |
Primary outcome
Best corrected visual acuity change (BCVA)
Time frame: 1, 3, 6, 12 month postoperatively
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Central subfield thickness (CST) change
Time frame: 1, 3, 6, 12 month postoperatively
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 37875997Guo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy combined with ILM peeling and Conbercept intravitreal injection in people with Diabetic Macular Edema and Pars Plana Vitrectomy, run by Tianjin Medical University Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojie Hu (13612130943, bhu07@tum.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity change (BCVA) (time frame: 1, 3, 6, 12 month postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05728476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.