Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Conbercept

+ Sham laser

+ Sham injection

DrugOtherProcedure
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2014
See protocol details

Summary

Principal SponsorChengdu Kanghong Biotech Co., Ltd.
Study ContactXun Xu, professor
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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) .

Official TitleSafety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
NCT02194634
Principal SponsorChengdu Kanghong Biotech Co., Ltd.
Study ContactXun Xu, professor
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

248 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
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.

Study 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

Recruiting

Peking University Third Hospital

Beijing, ChinaOpen Peking University Third Hospital in Google Maps
Recruiting

Beijing Tongren hospital affiliated to Capital Medical University

Beijing, China
Recruiting

Southwest Hospital

Chongqing, China
Recruiting

Daping Hospital, Research Institute of Surgery Third Military Medical University

Chongqing, China
Suspended17 Study Centers