Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

NCT02816710 | Completed Phase 4 Results

• 1 other identifier: 2016062501
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proliferative Diabetic Retinopathy; Tractional Retinal Detachment

Keywords

Conbercept; Proliferative diabetic retinopathy; Silicone oil tamponade

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Postoperative Preretinal Blood

  postoperatively, up to 1 week

• Reabsorption Time of Blood

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

• Recurrent Vitreous Hemorrhage

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

• Frequency of Intraoperative Electrocoagulation

  during the operation time

• Number of Participants With Neovascular Glaucoma (NVG)

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

Study Arms (3)

IVC Preoperative group

EXPERIMENTAL

Conbercept injection before vitrectomy

Drug: Conbercept

IVC Postoperative group

EXPERIMENTAL

Conbercept injection at the end of vitrectomy

Drug: Conbercept

IVC Pre- and Post-operative group

EXPERIMENTAL

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

Drug: Conbercept

Interventions

Conbercept 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; IVC Pre- and Post-operative group; IVC Preoperative group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China

Location

MeSH Terms

Interventions

KH902 fusion protein

Results Point of Contact

• Title: Dr. Xi Shen
• Organization: Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, 200025, Shanghai, China.

carl_shen2005@126.com

021-64370025

Study Officials

• Xi Shen, PhD

  Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 25, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 21, 2019
• Results First Posted: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)