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Molecular multiomics and multimodal imaging study of anti-VEGF preconditioning before minimally invasive vitrectomy in proliferative diabetic retinopathy

Molecular multiomics and multimodal imaging study of anti-VEGF preconditioning before minimally invasive vitrectomy in proliferative diabetic retinopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100448
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Interventions

Group A:Patients with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) were treated with intravitreal injection of faricizumab before vitrectomy (PPV)
Group B:Patients with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) were treated with intravitreal Aflibercept of faricizumab before vitrectomy (PPV)

Sponsors

Foshan Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients with diabetes aged 20-79; 2. Type 1 or type 2 diabetes; 3. Diagnosed with proliferative diabetic retinopathy (PDR) accompanied by neovascular membranes and/or TRD and/or refractory vitreous hematoma, requiring surgical intervention. 4. Inability to complete panretinal photocoagulation (PRP) due to vitreous hemorrhage (VH) or fibrovascular membranes from neovascularization. 5. Agreement to undergo anti-VEGF therapy prior to vitrectomy for PDR. 6. Participants must voluntarily agree to participate in the study, demonstrate the ability to comply with the study protocol and treatment plan, and commit to attending scheduled follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Patients who have received intravitreal anti-VEGF injections or retinal laser photocoagulation within the past 3 months. 2. Patients who have received intravitreal dexamethasone injections within the past 6 months or intravitreal steroid injections within the past 3 months. 3. Patients with a history of vitrectomy. 4. Diabetic retinopathy (DR) patients with a glycated hemoglobin (HbA1c) level exceeding 12%. 5. Patients with proliferative diabetic retinopathy (PDR) and severe vitreous hemorrhage that precludes observation of the vitreoretinal interface using optical coherence tomography angiography (OCTA). 6. Patients with concurrent severe ocular diseases other than PDR, such as glaucoma, macular degeneration, or other retinal vascular disorders. 7. Patients with active ocular infections or intraocular inflammation. 8. Patients with severe systemic conditions, including uncontrolled diabetes, uncontrolled hypertension, myocardial infarction within the past 6 months, or cerebrovascular accidents. 9. Patients with cognitive impairments, communication difficulties, or other conditions that may hinder adherence to the treatment protocol. 10. Patients with a known history of hypersensitivity to the study drugs, including aflibercept or faricimab or Aflibercept.

Design outcomes

Primary

MeasureTime frame
Aqueous humor cytokines(VEGF,IL-6,TNF-a,CTGF,PEDFMCP-1,ICAM-1,VCAM-1,Ang2);vision acuity;

Secondary

MeasureTime frame
Vitreoretinal junction blood flow;Glycosylated hemoglobin;Glomerular function;Serum creatinine;

Countries

China

Contacts

Public ContactYujuan Huang

Foshan Second People's Hospital

fs_sophia@126.com+86 158 2064 2880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026