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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02194634
• Date of registration: 14/07/2014
• Prospective Registration: No
• Primary sponsor: Chengdu Kanghong Biotech Co.,Ltd.
• Public title: Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
• Date of first enrolment: July 2014
• Target sample size: 248
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02194634
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Xun Xu, professor

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Macular Edema

Intervention(s)

Other: Sham injection

Other: Sham laser

Procedure: Laser

Drug: Conbercept

Primary Outcome(s)

Mean change from baseline in best corrected visual acuity (BCVA) at month 12 [Time Frame: Baseline and month 12]

Secondary Outcome(s)

Mean change from baseline in central retinal thickness (CRT) between two groups [Time Frame: Baseline and month 12]

Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection [Time Frame: 12 months]

Secondary ID(s)

KHSWKH902010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors