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The efficacy and safety of immediate intravitreal injection of ranibizumab after vitrectomy in patients with proliferative diabetic retinopathy

The efficacy and safety of immediate intravitreal injection of ranibizumab after vitrectomy in patients with proliferative diabetic retinopathy: A prospective, randomized controlled, multicenter study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107615
Enrollment
Unknown
Registered
2025-08-15
Start date
2025-08-29
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Proliferative diabetic retinopathy

Interventions

Experimental group:Immediately after PPV, a single intravitreal injection of ranibizumab (0.5mg/0.05mL) was used as usual after PPV
Control group:Immediate ranibizumab injection is not given after PPV, and conventional treatment after PPV is used

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes; 2. The eye with poor baseline best corrected visual acuity (BCVA) in both eyes at the time of the patient's visit was taken as the target eye, and the target eye was in line with the diagnosis of proliferative diabetic retinopathy. 3. The target eye has one or more of the following conditions that meet the surgical indications for vitrectomy (PPV) : non-absorbable vitreous hemorrhage, fibroproliferative membrane of PDR, preretinal hemorrhage, retinal traction and tractional retinal detachment, tractional rhegmatogenous retinal detachment, vitreous hemorrhage combined with cataract, vitreous hemorrhage combined with iris neovascularization, etc. 4. The patient's blood glucose and blood pressure were well controlled before the operation. 5. The subjects and their family members understand and agree to participate in this study, and have signed the informed consent; 6. Good compliance and high cooperation.

Exclusion criteria

Exclusion criteria: 1. In addition to intravitreal injection of ranibizumab or aflibercept, any other laser, surgical or injection treatments have been received within the past 3 months; 2. Known allergy or intolerance to anti-VEGF drugs; 3. Symptomatic visual loss caused by PDR more than 1 year; 4. Patients with various types of glaucoma or macular degeneration; 5. Thromboembolic event (including myocardial infarction or cerebrovascular event) in the past 6 months; 6. Known coagulation abnormalities or use of anticoagulants within 3 days;

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of major complications within 3 months after treatment: vitreous hemorrhage, choroidal detachment, macular epiretinal membrane, macular edema, anterior chamber reaction, iris adhe;Best corrected visual acuity (BCVA) at 3 months after treatment: the change in BCVA of the target eye from baseline to 3 months after treatment.;

Secondary

MeasureTime frame
Incidence and severity of adverse events;Central macular thickness measured by optical coherence tomography (OCT);Visual acuity was corrected at 1 week and 1 month after treatment;Proportion of patients requiring secondary treatment;

Countries

China

Contacts

Public ContactXian Zhang

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

zhangxiantjyk@163.com+86 158 7243 2973

Outcome results

None listed

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