Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
NCT ID: NCT02194634
Last Updated: 2016-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
248 participants
INTERVENTIONAL
2014-07-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Conbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
Sham laser
Sham laser at first month, then repeated as needed.
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.
Sham injection
Sham intravitreal injection at first month, then repeated as needed.
Laser
Laser treatment at first month, then repeated as needed.
Interventions
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Conbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
Sham injection
Sham intravitreal injection at first month, then repeated as needed.
Laser
Laser treatment at first month, then repeated as needed.
Sham laser
Sham laser at first month, then repeated as needed.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Chengdu Kanghong Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
Daping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, China
Zhongshan Ophthalmic Center , Sun Yat-Sen University
Guangzhou, Guangdong, China
Eye hospital of Henan province
Zhengzhou, Henan, China
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
He eye hospital
Shenyang, Liaoning, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Renji hospital shanghai jiaotong university school of medcine
Shanghai, Shanghai Municipality, China
Xijing Hospital
Xian, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Eye center of Tianjin mendical university
Tianjin, Tianjin Municipality, China
The Affiliated Eye Hospital of WMC
Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Xun Xu, professor
Role: CONTACT
References
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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.
Other Identifiers
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KHSWKH902010
Identifier Type: -
Identifier Source: org_study_id
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