Clinical trial NCT02194634: Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in best corrected visual acuity (BCVA) at month 12
timeFrame: Baseline and month 12
Secondary outcomes:
measure: Mean change from baseline in central retinal thickness (CRT) between two groups
timeFrame: Baseline and month 12
measure: Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection
timeFrame: 12 months
Other outcomes:
measure: Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc.
timeFrame: Baseline and every month, up to 12 months
measure: Mean change from baseline BCVA between treatment group and controlled group
timeFrame: Baseline and every month, up to 12 months
measure: Change from baseline in visual acuity distribution of treatment group and controlled group
timeFrame: Month 6, month 12
measure: 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
timeFrame: Month 6, month 12
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren hospital affiliated to Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital, Research Institute of Surgery Third Military Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center , Sun Yat-Sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Eye hospital of Henan province
state: Henan
city: Wuhan
country: China
facility: Wuhan General Hospital of Guangzhou Military
state: Hubei
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: He eye hospital
state: Liaoning
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji hospital shanghai jiaotong university school of medcine
state: Shanghai
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Eye center of Tianjin mendical university
state: Tianjin
city: Wenzhou
country: China
facility: The Affiliated Eye Hospital of WMC
state: Zhejiang
city: Bei jing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
citation: 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.