Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)

This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .

Study Overview

• Status: Unknown
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Conbercept; Other: Sham laser; Other: Sham injection; Procedure: Laser

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xun Xu, professor; Phone Number: 86-21-63240090

Study Locations

• China
  • Bei jing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Principal Investigator: Junjie Ye, professor
  • Beijing
    • Beijing, Beijing, China, 100083
      • Recruiting
      • Peking University Third Hospital
      • Principal Investigator: Yuling Liu, professor
    • Beijing, Beijing, China, 100044
      • Completed
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Tongren Hospital Affiliated to Capital Medical University
      • Principal Investigator: Feng Zhang, professor
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital
      • Principal Investigator: Shaojun Chen, professor
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Daping Hospital, Research Institute of Surgery Third Military Medical University
      • Principal Investigator: Jian Ye, professor
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Not yet recruiting
      • Zhongshan Ophthalmic Center , Sun Yat-Sen University
      • Principal Investigator: Xiao ling Liang, professor
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Eye hospital of Henan province
      • Principal Investigator: Ke Fan
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Recruiting
      • Wuhan General Hospital of Guangzhou Military
      • Principal Investigator: Yanping Song, professor
  • Jiangsu
    • Wuxi, Jiangsu, China, 214002
      • Recruiting
      • Wuxi No.2 People's Hospital
      • Principal Investigator: Zhifeng Wu, professor
  • Liaoning
    • Shenyang, Liaoning, China, 110034
      • Recruiting
      • He Eye Hospital
      • Principal Investigator: Wei He, Doctor
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Recruiting
      • Shanghai First People's Hospital
      • Principal Investigator: Xun Xu, professor
      • Principal Investigator: Kun Liu, doctor
    • Shanghai, Shanghai, China
      • Recruiting
      • Renji hospital shanghai jiaotong university school of medcine
  • Shanxi
    • Xian, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Principal Investigator: Yusheng Wang, professor
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Principal Investigator: Junjun Zhang, professor
  • Tianjin
    • Tianjin, Tianjin, China, 300070
      • Recruiting
      • Eye center of Tianjin mendical university
      • Principal Investigator: Zhi qing Li
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • The Affiliated Eye Hospital of WMC
      • Principal Investigator: Xiaoling Liu, professor

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. Patients sign informed consent, and are willing and able to comply with all the follow-ups;
2. Age ≥ 18 years , both genders;
3. Diagnosis of type 1 or type 2 diabetes mellitus;
4. Serum HbA1c ≤ 10%;

5. Study eye must meet the following criteria:

   • Visual acuity impairment caused by DME with involving foveal;
   • BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to 20/320);
   • Visual impairment due to Choroidal Neovascularization (CNV) secondary to high myopia.
   • Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence Tomography (OCT), the CRT measurements must be confirmed by central reading center);
   • Refractive media opacities and miosis have no effect on the fundus examination.
6. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).

Exclusion Criteria:

1. Active infectious ocular inflammation in either eye;
2. Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;
3. Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;
4. Iris neovascularization in the study eye;
5. Uncontrolled glaucoma, or history of glaucoma surgery;
6. Aphakia in the study eye;
7. History of vitrectomy in the study eye;
8. History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study;
9. Liver, kidney dysfunction;
10. History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conbercept treatment group; Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.	Drug: Conbercept; Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.; Other: Sham laser; Sham laser at first month, then repeated as needed.
Active Comparator: Laser treatment group; Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.	Other: Sham injection; Sham intravitreal injection at first month, then repeated as needed.; Procedure: Laser; Laser treatment at first month, then repeated as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in best corrected visual acuity (BCVA) at month 12	To compare mean change from baseline BCVA between treatment group and controlled group at month 12.	Baseline and month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in central retinal thickness (CRT) between two groups	To compare mean change from baseline CRT between two groups at month 12.	Baseline and month 12
Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection	To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc.	Baseline and every month, up to 12 months
Mean change from baseline BCVA between treatment group and controlled group	Baseline and every month, up to 12 months
Change from baseline in visual acuity distribution of treatment group and controlled group	Month 6, month 12
The 25-item National Eye Institute Visual Function Questionnaire （NEI VFQ-25）total score mean change from baseline of between treatment group and controlled group	Month 6, month 12

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Publications and helpful links

General Publications

• Liu K, Wang H, He W, Ye J, Song Y, Wang Y, Liu X, Wu Z, Chen S, Fan K, Liu Y, Zhang F, Li Z, Liu L, Zhang J, Zhang X, Ye J, Liang X, Li X, Ke X, Wu Q, Li J, Tao S, Wang X, Rosenfeld P, Heier JS, Kaiser P, Xu X. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. Br J Ophthalmol. 2022 Oct;106(10):1436-1443. doi: 10.1136/bjophthalmol-2020-318690. Epub 2021 May 17.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: KHSWKH902010