This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05728476
Recruitment Status : Not yet recruiting
First Posted : February 15, 2023
Last Update Posted : October 5, 2023
Sponsor:
Information provided by (Responsible Party):
Bojie Hu, Tianjin Medical University Eye Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Pars Plana Vitrectomy Conbercept Procedure: Vitrectomy combined with ILM peeling Drug: Conbercept intravitreal injection Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
Estimated Study Start Date : November 1, 2023
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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.
Procedure: Vitrectomy combined with ILM peeling
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.
Drug: Conbercept intravitreal injection
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 Measures :
  1. Best corrected visual acuity change (BCVA) [ Time Frame: 1, 3, 6, 12 month postoperatively ]
    Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart

  2. Central subfield thickness (CST) change [ Time Frame: 1, 3, 6, 12 month postoperatively ]
    Three-dimensional spectral domain optical coherence tomography (SD-OCT)


Secondary Outcome Measures :
  1. The stage of diabetic retinopathy (DR) [ Time Frame: 12 month postoperatively ]
    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.

  2. Cost-effectiveness analysis [ Time Frame: 12 month postoperatively ]
    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.

  3. Vision-related quality of life questionnaire [ Time Frame: 6, 12 month postoperatively ]
    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.

  4. Biomarkers of optical coherence tomography (OCT) [ Time Frame: 1, 3, 6, 12 month postoperatively ]
    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.

  5. Biomarkers of OCT angiography (OCTA) [ Time Frame: 1, 3, 6, 12 month postoperatively ]
    The scanning area, centred on the fovea, was captured in 3×3 mm sections with a resolution of 304×304 pixels.

  6. Occurrence rates of re-treatment [ Time Frame: 12 months postoperatively ]
    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.

  7. Occurrence rates of adverse events [ Time Frame: 12 months postoperatively ]
    Ocular hypertension, progression of cataract, corneal abrasion, retinal injury, hyphaemia, uveitis or inflammatory reaction, and endophthalmitis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05728476


Contacts
Layout table for location contacts
Contact: Bojie Hu 13612130943 bhu07@tum.edu.cn

Locations
Layout table for location information
China, Tianjin
Tianjin medical university eye hosipital
Tianjin, Tianjin, China
Contact: Bojie Hu    13612130943    bhu07@tmu.edu.cn   
Sponsors and Collaborators
Tianjin Medical University Eye Hospital
Layout table for additonal information
Responsible Party: Bojie Hu, Professor, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier: NCT05728476    
Other Study ID Numbers: TianjinMUEHhbj111
First Posted: February 15, 2023    Key Record Dates
Last Update Posted: October 5, 2023
Last Verified: October 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases