Diabetic Macular Edema
Conditions
Brief summary
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) .
Interventions
DRUGConbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
OTHERSham injection
Sham intravitreal injection at first month, then repeated as needed.
PROCEDURELaser
Laser treatment at first month, then repeated as needed.
OTHERSham laser
Sham laser at first month, then repeated as needed.
Sponsors
Chengdu Kanghong Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in best corrected visual acuity (BCVA) at month 12 | Baseline and month 12 | To compare mean change from baseline BCVA between treatment group and controlled group at month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in central retinal thickness (CRT) between two groups | Baseline and month 12 | To compare mean change from baseline CRT between two groups at month 12. |
| Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection | 12 months | To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc. |
Other
| Measure | Time frame |
|---|---|
| Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc. | Baseline and every month, up to 12 months |
| The 25-item National Eye Institute Visual Function Questionnaire （NEI VFQ-25）total score mean change from baseline of between treatment group and controlled group | Month 6, month 12 |
| Mean change from baseline BCVA between treatment group and controlled group | Baseline and every month, up to 12 months |
| Change from baseline in visual acuity distribution of treatment group and controlled group | Month 6, month 12 |
Countries
China
Contacts
Primary ContactXun Xu, professor
Outcome results
None listed