Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
NCT02194634 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248
Last updated 2016-01-06
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) .
Conditions
Interventions
- DRUG
-
Conbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
- OTHER
-
Sham injection
Sham intravitreal injection at first month, then repeated as needed.
- PROCEDURE
-
Laser
Laser treatment at first month, then repeated as needed.
- OTHER
-
Sham laser
Sham laser at first month, then repeated as needed.
Sponsors & Collaborators
-
Chengdu Kanghong Biotech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2016-12-31
- Completion
- 2017-09-30
Countries
- China
Study Locations
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