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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02194634
• Other study ID #: KHSWKH902010
• Status: Recruiting
• Phase: Phase 3
• First received: July 14, 2014
• Last updated: January 5, 2016
• Start date: July 2014
• Est. completion date: September 2017

Study information

• Verified date: June 2015
• Source: Chengdu Kanghong Biotech Co.,Ltd.
• Contact: Xun Xu, professor
• Phone: 86-21-63240090
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: September 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Conbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.

Other:
• Sham injection
Sham intravitreal injection at first month, then repeated as needed.

Procedure:
• Laser
Laser treatment at first month, then repeated as needed.

Other:
• Sham laser
Sham laser at first month, then repeated as needed.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Bei jing
China	Beijing Tongren hospital affiliated to Capital Medical University	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Daping Hospital, Research Institute of Surgery Third Military Medical University	Chongqing	Chongqing
China	Southwest Hospital	Chongqing	Chongqing
China	Zhongshan Ophthalmic Center , Sun Yat-Sen University	Guangzhou	Guangdong
China	Renji hospital shanghai jiaotong university school of medcine	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	He eye hospital	Shenyang	Liaoning
China	Eye center of Tianjin mendical university	Tianjin	Tianjin
China	The Affiliated Eye Hospital of WMC	Wenzhou	Zhejiang
China	Wuhan General Hospital of Guangzhou Military	Wuhan	Hubei
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu
China	Xijing Hospital	Xian	Shanxi
China	Eye hospital of Henan province	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Kanghong Biotech Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Mean change from baseline BCVA between treatment group and controlled group		Baseline and every month, up to 12 months	No
Other	Change from baseline in visual acuity distribution of treatment group and controlled group		Month 6, month 12	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	Yes