Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
1 other identifier
interventional
248
1 country
17
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2014
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 6, 2016
June 1, 2015
2.4 years
July 14, 2014
January 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mean change from baseline in central retinal thickness (CRT) between two groups
Baseline and month 12
Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection
12 months
Other Outcomes (4)
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
- +1 more other outcomes
Study Arms (2)
Conbercept treatment group
EXPERIMENTALConbercept 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
ACTIVE COMPARATORLaser 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.
Interventions
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
Sham intravitreal injection at first month, then repeated as needed.
Eligibility Criteria
You may qualify if:
- Patients sign informed consent, and are willing and able to comply with all the follow-ups;
- Age ≥ 18 years , both genders;
- Diagnosis of type 1 or type 2 diabetes mellitus;
- Serum HbA1c ≤ 10%;
- 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.
- Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).
You may not qualify if:
- Active infectious ocular inflammation in either eye;
- Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;
- Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;
- Iris neovascularization in the study eye;
- Uncontrolled glaucoma, or history of glaucoma surgery;
- Aphakia in the study eye;
- History of vitrectomy in the study eye;
- 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;
- Liver, kidney dysfunction;
- History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100083, China
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730, China
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
Daping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Zhongshan Ophthalmic Center , Sun Yat-Sen University
Guangzhou, Guangdong, 510060, China
Eye hospital of Henan province
Zhengzhou, Henan, 450003, China
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, 430070, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002, China
He eye hospital
Shenyang, Liaoning, 110034, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
Renji hospital shanghai jiaotong university school of medcine
Shanghai, Shanghai Municipality, China
Xijing Hospital
Xian, Shanxi, 710032, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Eye center of Tianjin mendical university
Tianjin, Tianjin Municipality, 300070, China
The Affiliated Eye Hospital of WMC
Wenzhou, Zhejiang, 325027, China
Peking Union Medical College Hospital
Beijing, 100730, China
Related Publications (1)
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.
PMID: 34001667DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 18, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2016
Study Completion
September 1, 2017
Last Updated
January 6, 2016
Record last verified: 2015-06