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

Phase 3

• Conditions: Diabetic Macular Edema
• Interventions: Other: Sham injection; Drug: Conbercept; Other: Sham laser; Procedure: Laser

• Registration Number: NCT02194634
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Brief Summary

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Status Verified: 2015-06
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06
• Primary Completion: 2016-12
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conbercept treatment group	Sham laser	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.
Laser treatment group	Sham injection	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.
Laser treatment group	Laser	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.
Conbercept treatment group	Conbercept	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (17)

Beijing Tongren hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China

Daping Hospital, Research Institute of Surgery Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Zhongshan Ophthalmic Center , Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Wuhan General Hospital of Guangzhou Military; 🇨🇳 Wuhan, Hubei, China

Renji hospital shanghai jiaotong university school of medcine; 🇨🇳 Shanghai, Shanghai, China

Eye hospital of Henan province; 🇨🇳 Zhengzhou, Henan, China

Wuxi No.2 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Xijing Hospital; 🇨🇳 Xian, Shanxi, China

He eye hospital; 🇨🇳 Shenyang, Liaoning, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Bei jing, China

Eye center of Tianjin mendical university; 🇨🇳 Tianjin, Tianjin, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The Affiliated Eye Hospital of WMC; 🇨🇳 Wenzhou, Zhejiang, China