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

Study Overview
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Brief Summary
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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
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Conbercept
* Other: Sham injection
* Procedure: Laser
* Other: Sham laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients sign informed consent, and are willing and able to comply with all the follow-ups; Age ≥ 18 years , both genders; Diagnosis of type 1 or type 2 diabetes mellitus; Serum HbA1c ≤ 10%; 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. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320). Exclusion Criteria: Active infectious ocular inflammation in either eye; Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR; Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy; Iris neovascularization in the study eye; Uncontrolled glaucoma, or history of glaucoma surgery; Aphakia in the study eye; History of vitrectomy in the study eye; 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; Liver, kidney dysfunction; History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conbercept treatment group<br>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<br>* Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.<br>Other: Sham laser<br>* Sham laser at first month, then repeated as needed.<br>|
| Active Comparator: Laser treatment group<br>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<br>* Sham intravitreal injection at first month, then repeated as needed.<br>Procedure: Laser<br>* Laser treatment at first month, then repeated as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best corrected visual acuity (BCVA) at month 12 | To compare mean change from baseline BCVA between treatment group and controlled group at month 12. | Baseline and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in central retinal thickness (CRT) between two groups | To compare mean change from baseline CRT between two groups at month 12. | Baseline and month 12 | 
| Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection | To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc. | 12 months |