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

Kanghong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: Conbercept; Other: Sham injection; Other: Sham laser; Procedure: Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194634

KHSWKH902010

Details and patient eligibility

About

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) .

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 2 patient groups

Conbercept treatment group

Experimental group

Description:

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.

Treatment:

Other: Sham laser

Drug: Conbercept

Laser treatment group

Active Comparator group

Description:

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.

Treatment:

Procedure: Laser

Other: Sham injection