Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy

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

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy; Tractional Retinal Detachment
• Intervention / Treatment: Drug: Conbercept

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20025
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVC Preoperative group; Conbercept injection before vitrectomy	Drug: 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.
Experimental: IVC Postoperative group; Conbercept injection at the end of vitrectomy	Drug: 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.
Experimental: IVC Pre- and Post-operative group; First conbercept injection before vitrectomy and second at the end of operation.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected Visual Acuity		6 months
Duration of Surgery	To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.	during the operation time
Intraoperative Bleeding	The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.	Time between the insertion and extraction of three 23-gauge vitrectomy ports

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Preretinal Blood	The grading criteria for postoperative preretinal blood: Grade 1, isolated blood clots within 10 disk area but without covering the posterior pole; Grade 2, broad blood clots exceeding 10 disk area regardless of involvement of the posterior pole; Grade 3, broad blood clots exceeding 10 disk area as well as involving the posterior pole. Maximal extent of preretinal blood within 1 week postoperatively was used for grading the extent of hemorrhage.	postoperatively, up to 1 week
Reabsorption Time of Blood	To monitor the reabsorption time of preretinal blood.	follow up period, up to an average of 6 months after the operation
Recurrent Vitreous Hemorrhage	Recurrent vitreous hemorrhage(VH) was referred to any new episode of VH occurring after one week postoperatively, dividing into early stage (≤ 4 weeks) and late stage (> 4 weeks).	follow up period, up to an average of 6 months after the operation
Frequency of Intraoperative Electrocoagulation	The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.	during the operation time
Number of Participants With Neovascular Glaucoma (NVG)		follow up period, up to an average of 6 months after the operation
Recurrent Retinal Detachment		follow up period, up to an average of 6 months after the operation
Need for Reoperation	due to recurrent retinal detachment or unclear vitreous hemorrhage	follow up period, up to an average of 6 months after the operation

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Xi Shen, PhD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 25, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 2, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Conbercept; Proliferative diabetic retinopathy; Silicone oil tamponade
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Retinal Detachment
• Other Study ID Numbers: 2016062501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO