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

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ClinicalTrials.gov Identifier: NCT02194634
Recruitment Status : Unknown
Verified June 2015 by Chengdu Kanghong Biotech Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 18, 2014
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
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) .

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Conbercept Other: Sham injection Procedure: Laser Other: Sham laser Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: 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.
Drug: Conbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.

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

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

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




Primary Outcome Measures :
  1. Mean change from baseline in best corrected visual acuity (BCVA) at month 12 [ Time Frame: Baseline and month 12 ]
    To compare mean change from baseline BCVA between treatment group and controlled group at month 12.


Secondary Outcome Measures :
  1. Mean change from baseline in central retinal thickness (CRT) between two groups [ Time Frame: Baseline and month 12 ]
    To compare mean change from baseline CRT between two groups at month 12.

  2. Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection [ Time Frame: 12 months ]
    To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.


Other Outcome Measures:
  1. Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc. [ Time Frame: Baseline and every month, up to 12 months ]
  2. Mean change from baseline BCVA between treatment group and controlled group [ Time Frame: Baseline and every month, up to 12 months ]
  3. Change from baseline in visual acuity distribution of treatment group and controlled group [ Time Frame: Month 6, month 12 ]
  4. 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 [ Time Frame: Month 6, month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194634


Contacts
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Contact: Xun Xu, professor 86-21-63240090

Locations
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China, Beijing
Peking University People's Hospital Completed
Beijing, Beijing, China, 100044
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100083
Principal Investigator: Yuling Liu, professor         
Beijing Tongren hospital affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100730
Principal Investigator: Feng Zhang, professor         
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Principal Investigator: Shaojun Chen, professor         
Daping Hospital, Research Institute of Surgery Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Principal Investigator: Jian Ye, professor         
China, Guangdong
Zhongshan Ophthalmic Center , Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510060
Principal Investigator: Xiao ling Liang, professor         
China, Henan
Eye hospital of Henan province Recruiting
Zhengzhou, Henan, China, 450003
Principal Investigator: Ke Fan         
China, Hubei
Wuhan General Hospital of Guangzhou Military Recruiting
Wuhan, Hubei, China, 430070
Principal Investigator: Yanping Song, professor         
China, Jiangsu
Wuxi No.2 People's Hospital Recruiting
Wuxi, Jiangsu, China, 214002
Principal Investigator: Zhifeng Wu, professor         
China, Liaoning
He eye hospital Recruiting
Shenyang, Liaoning, China, 110034
Principal Investigator: Wei He, Doctor         
China, Shanghai
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China, 200080
Principal Investigator: Xun Xu, professor         
Principal Investigator: Kun Liu, doctor         
Renji hospital shanghai jiaotong university school of medcine Recruiting
Shanghai, Shanghai, China
Principal Investigator: Lin Liu         
China, Shanxi
Xijing Hospital Recruiting
Xian, Shanxi, China, 710032
Principal Investigator: Yusheng Wang, professor         
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Principal Investigator: Junjun Zhang, professor         
China, Tianjin
Eye center of Tianjin mendical university Recruiting
Tianjin, Tianjin, China, 300070
Principal Investigator: Zhi qing Li         
China, Zhejiang
The Affiliated Eye Hospital of WMC Recruiting
Wenzhou, Zhejiang, China, 325027
Principal Investigator: Xiaoling Liu, professor         
China
Peking Union Medical College Hospital Recruiting
Bei jing, China, 100730
Principal Investigator: Junjie Ye, professor         
Sponsors and Collaborators
Chengdu Kanghong Biotech Co., Ltd.

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Responsible Party: Chengdu Kanghong Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02194634     History of Changes
Other Study ID Numbers: KHSWKH902010
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: June 2015

Additional relevant MeSH terms:
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Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases