Trial · NCT05728476
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
NCT05728476, Not applicable, Unknown, Tianjin Medical University Eye Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema. Trials, record NCT05728476. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05728476
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
- NCT number
- NCT05728476
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 102 participants, estimated
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Conditions
- Diabetic Macular Edema, Pars Plana Vitrectomy, Conbercept
- Interventions
- Vitrectomy combined with ILM peeling, Conbercept intravitreal injection
- First posted
- 2023-02-15
- Last updated
- 2024-03-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best corrected visual acuity change (BCVA) | 1, 3, 6, 12 month postoperatively | Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart |
| Primary | Central subfield thickness (CST) change | 1, 3, 6, 12 month postoperatively | Three-dimensional spectral domain optical coherence tomography (SD-OCT) |
| Secondary | The stage of diabetic retinopathy (DR) | 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. |
| Secondary | Cost-effectiveness analysis | 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. |
| Secondary | Vision-related quality of life questionnaire | 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. |
| Secondary | Biomarkers of optical coherence tomography (OCT) | 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. |
| Secondary | Biomarkers of OCT angiography (OCTA) | 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. |
| Secondary | Occurrence rates of re-treatment | 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. |
| Secondary | Occurrence rates of adverse events | 12 months postoperatively | Ocular hypertension, progression of cataract, corneal abrasion, retinal injury, hyphaemia, uveitis or inflammatory reaction, and endophthalmitis. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37875997 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05728476
GET https://conductscience.org/api/trials/v1/NCT05728476/registered