Clinical trial NCT02816710: Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy
Official title: Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Proliferative Diabetic Retinopathy
Tractional Retinal Detachment
Keywords: Conbercept
Proliferative diabetic retinopathy
Silicone oil tamponade
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Best-corrected Visual Acuity
timeFrame: 6 months
measure: Duration of Surgery
timeFrame: during the operation time
measure: Intraoperative Bleeding
timeFrame: Time between the insertion and extraction of three 23-gauge vitrectomy ports
Secondary outcomes:
measure: Postoperative Preretinal Blood
timeFrame: postoperatively, up to 1 week
measure: Reabsorption Time of Blood
timeFrame: follow up period, up to an average of 6 months after the operation
measure: Recurrent Vitreous Hemorrhage
timeFrame: follow up period, up to an average of 6 months after the operation
measure: Frequency of Intraoperative Electrocoagulation
timeFrame: during the operation time
measure: Number of Participants With Neovascular Glaucoma (NVG)
timeFrame: follow up period, up to an average of 6 months after the operation
measure: Recurrent Retinal Detachment
timeFrame: follow up period, up to an average of 6 months after the operation
measure: Need for Reoperation
timeFrame: follow up period, up to an average of 6 months after the operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Xi Shen, PhD
role: STUDY_DIRECTOR
References: