Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital

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.