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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Conbercept Other: Sham injection Procedure: Laser Other: Sham laser||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||September 2017|
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.
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.
Laser treatment at first month, then repeated as needed.
- 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.
- 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.
- 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.
- 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 ]
- Mean change from baseline BCVA between treatment group and controlled group [ Time Frame: Baseline and every month, up to 12 months ]
- Change from baseline in visual acuity distribution of treatment group and controlled group [ Time Frame: Month 6, month 12 ]
- 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 ]
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
|Contact: Xun Xu, professor||86-21-63240090|