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Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy, Tractional Retinal Detachment

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Conbercept

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Conbercept, Proliferative diabetic retinopathy, Silicone oil tamponade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects of either sex aged ≥ 18 years.
Diagnosis of diabetes mellitus (type 1 or type 2);
Active proliferative diabetic retinopathy was clinically evident;
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.
Ability to give informed consent.

Exclusion Criteria:

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

Sites / Locations

Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

IVC Preoperative group

IVC Postoperative group

IVC Pre- and Post-operative group

Arm Description

Conbercept injection before vitrectomy

Conbercept injection at the end of vitrectomy

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

Outcomes

Primary Outcome Measures

Best-corrected Visual Acuity

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.

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.

Secondary Outcome Measures

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.

Reabsorption Time of Blood

To monitor the reabsorption time of preretinal blood.

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).

Frequency of Intraoperative Electrocoagulation

The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.

Number of Participants With Neovascular Glaucoma (NVG)

Recurrent Retinal Detachment

Need for Reoperation

due to recurrent retinal detachment or unclear vitreous hemorrhage

Full Information

NCT ID

NCT02816710

First Posted

June 25, 2016

Last Updated

November 2, 2019

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02816710

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy, Tractional Retinal Detachment

Keywords

Conbercept, Proliferative diabetic retinopathy, Silicone oil tamponade

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IVC Preoperative group

Arm Type

Experimental

Arm Description

Conbercept injection before vitrectomy

Arm Title

IVC Postoperative group

Arm Type

Experimental

Arm Description

Conbercept injection at the end of vitrectomy

Arm Title

IVC Pre- and Post-operative group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Conbercept

Intervention Description

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.

Primary Outcome Measure Information:

Title

Best-corrected Visual Acuity

Time Frame

6 months

Title

Duration of Surgery

Description

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.

Time Frame

during the operation time

Title

Intraoperative Bleeding

Description

Time Frame

Time between the insertion and extraction of three 23-gauge vitrectomy ports

Secondary Outcome Measure Information:

Title

Postoperative Preretinal Blood

Description

Time Frame

postoperatively, up to 1 week

Title

Reabsorption Time of Blood

Description

To monitor the reabsorption time of preretinal blood.

Time Frame

follow up period, up to an average of 6 months after the operation

Title

Recurrent Vitreous Hemorrhage

Description

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).

Time Frame

follow up period, up to an average of 6 months after the operation

Title

Frequency of Intraoperative Electrocoagulation

Description

The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.

Time Frame

during the operation time

Title

Number of Participants With Neovascular Glaucoma (NVG)

Time Frame

follow up period, up to an average of 6 months after the operation

Title

Recurrent Retinal Detachment

Time Frame

follow up period, up to an average of 6 months after the operation

Title

Need for Reoperation

Description

due to recurrent retinal detachment or unclear vitreous hemorrhage

Time Frame

follow up period, up to an average of 6 months after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects of either sex aged ≥ 18 years. Diagnosis of diabetes mellitus (type 1 or type 2); Active proliferative diabetic retinopathy was clinically evident; 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. Ability to give informed consent. Exclusion Criteria: Coexistent ocular disease that may interfere with visual outcome; Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye; A macula-involving retinal detachment for >6 months in the study eye; Iris or angle neovascularization and neovascular glaucoma; known allergy to any components of conbercept formulation severe external ocular infection; pregnancy or current oral contraceptive intake; usage of anticoagulant or antiplatelet therapy; preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%]; uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases; <6 months of follow-up post initial surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xi Shen, PhD

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

20025

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

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