Skip to content

Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy

Efficacy and Safety Comparison of Ranibizumab and Conbercept Pretreatment Before Vitrectomy in Proliferative Diabetic Retinopathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05414149
Enrollment
80
Registered
2022-06-10
Start date
2021-09-01
Completion date
2022-05-31
Last updated
2022-06-10

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

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathy; ranibizumab; conbercept

Brief summary

Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).Although pars plana vitrectomy (PPV) is the cornerstone for treatment of advanced PDR, related postoperative complications such as recurrent VH, NVG, and postoperative fibrovascular proliferation progression may still cause serious visual impairment. Preoperative intravitreal injections of anti-VEGF drugs may represent a new strategy for making vitrectomy safer and more effective for severe PDR.

Detailed description

Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).It is characterized by progressive loss of vision, retinal edema, vitreous hemorrhage (VH), retinal neovascularization, fibrovascular proliferation, tractional retinal detachment (TRD) and neovascular glaucoma (NVG).Although pars plana vitrectomy (PPV) is the cornerstone for treatment of advanced PDR, related postoperative complications such as recurrent VH, NVG, and postoperative fibrovascular proliferation progression may still cause serious visual impairment. It is well known that vascular endothelial growth factor (VEGF) is a leading role of the neovascularization, vascular permeability, and diabetic macular edema.preoperative intravitreal injections of anti-VEGF drugs may represent a new strategy for making vitrectomy safer and more effective for severe PDR.Until now, there are two kinds of anti-VEGF drugs in China, including monoclonal antibodies, like imported drug Ranibizumab, militating by block VEGF-A, and fusion proteins, like domectic drug Conbercept, competitively inhibiting the binding of VEGF with its receptor by blocking multiple targets, VEGF-A, VEGF-B, and placental insulin-like growth factor (PlGF). Studies focusing on the comparison of efficacy between preoperative intravitreal injections of the two drugs for patients with severe PDR undergoing vitrectomy is still limited. Thus, in this study, we aim to carry out a more comprehensive comparison in intraoperative and postoperative aspects on the efficacy and safety between intravitreal ranibizumab injection (IVR) and intravitreal conbercept injection (IVC) before vitrectomy of PDR.

Interventions

PROCEDUREpreoperative intravitreal injections of ranibizumab or conbercept

IVR group means patients received intravitreal ranibizumab injections (IVR) (0.5mg/0.05ml) before vitreous surgery. IVC group means patients that received intravitreal conbercept injection (IVC) (0.5mg/0.05ml) before vitreous surgery.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with diabetic retinopathy (DR); hemoglobin A1c (HbA1c) ≤ 12%; * persistent VH for more than 1 month or recurrent vitreous hemorrhage (VH) with or without panretinal photocoagulation (PRP); * TRD detected by indirect ophthalmoscope or B-scan ultrasonography.

Exclusion criteria

* previous vitreoretinal surgeries (including vitrectomy, intravitreal drug injection) in the study eyes; * eyes with any ocular disease that may hinder visual improvement other than PDR, such as optic atrophy or macular hole; * history of thromboembolic events (including cerebral vascular infarctions or myocardial infarctions) or coagulation system disorders or receiving anticoagulant or antiplatelet therapy; * eyes given gas tamponade or additional treatment like ranibizumab injection again or supplementary retinal photocoagulation during follow-up periods.

Design outcomes

Primary

MeasureTime frameDescription
BCVAfrom preoperation to 3 months follow-upbest-corrected visual acuity
CRTfrom preoperation to 3 months follow-upcentral retinal thickness

Secondary

MeasureTime frameDescription
intraocular electrocoagulation useduring surgeryintraocular electrocoagulation use
incidence of iatrogenic retinal breaksduring surgeryincidence of iatrogenic retinal breaks
relaxing retinotomyduring surgeryrelaxing retinotomy
retinal reattachmentduring surgeryretinal reattachment
surgery timeduring surgerysurgery time
postoperative vitreous hemorrhage (VH)during 3 months follow-uppostoperative vitreous hemorrhage (VH)
neovascular glaucoma (NVG)during 3 months follow-upneovascular glaucoma (NVG)
recurrent retinal detachmentduring 3 months follow-uprecurrent retinal detachment
postoperative fibrovascular proliferation progressionduring 3 months follow-uppostoperative fibrovascular proliferation progression
silicone oil tamponadeduring surgerysilicone oil tamponade
intraoperative bleedingduring surgeryintraoperative bleeding

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026