Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
Conbercept
+ Sham laser
+ Sham injection
Treatment Study
Summary
Study start date: July 1, 2014
Actual date on which the first participant was enrolled.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) .
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.248 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, ChinaSouthwest Hospital
Chongqing, ChinaDaping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, China