Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Proliferative Diabetic Retinopathy; Tractional Retinal Detachment

Treatments: Drug: Conbercept

Study type: Interventional

Funder types: Other

Identifiers

NCT02816710

2016062501

Details and patient eligibility

About

To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.

Full description

To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects of either sex aged ≥ 18 years.
2. Diagnosis of diabetes mellitus (type 1 or type 2);
3. Active proliferative diabetic retinopathy was clinically evident;
4. Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
5. Ability to give informed consent.

Exclusion criteria

1. Coexistent ocular disease that may interfere with visual outcome;
2. Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
3. A macula-involving retinal detachment for >6 months in the study eye;
4. Iris or angle neovascularization and neovascular glaucoma;
5. known allergy to any components of conbercept formulation
6. severe external ocular infection;
7. pregnancy or current oral contraceptive intake;
8. usage of anticoagulant or antiplatelet therapy;
9. preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%];
10. uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases;
11. <6 months of follow-up post initial surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 3 patient groups

IVC Preoperative group

Experimental group

Description:

Conbercept injection before vitrectomy

Treatment:

Drug: Conbercept

IVC Postoperative group

Experimental group

Description:

Conbercept injection at the end of vitrectomy

Treatment:

Drug: Conbercept

IVC Pre- and Post-operative group

Experimental group

Description:

First conbercept injection before vitrectomy and second at the end of operation.

Treatment:

Drug: Conbercept