Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

NCT ID: NCT02816710

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-09-30

Brief Summary

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

Detailed 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.

Conditions

Proliferative Diabetic Retinopathy; Tractional Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVC Preoperative group

Conbercept injection before vitrectomy

Group Type: EXPERIMENTAL

Conbercept

Intervention Type: DRUG

Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

IVC Postoperative group

Conbercept injection at the end of vitrectomy

Group Type: EXPERIMENTAL

Conbercept

Intervention Type: DRUG

Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

IVC Pre- and Post-operative group

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

Group Type: EXPERIMENTAL

Conbercept

Intervention Type: DRUG

Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

Interventions

Conbercept

Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xi Shen

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xi Shen, PhD

Role: STUDY_DIRECTOR

Shanghai Jiao Tong University School of Medicine

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016062501

Identifier Type: -

Identifier Source: org_study_id