Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conbercept treatment group | 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. |
|
| Laser treatment group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept | Drug | Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed. |
|
| 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 |
| 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 |
| Measure | Description | 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 | |
| Mean change from baseline BCVA between treatment group and controlled group | Baseline and every month, up to 12 months |
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:
Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xun Xu, professor | Contact | 86-21-63240090 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Completed | Beijing | Beijing Municipality | 100044 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34001667 | Derived | Liu K, Wang H, He W, Ye J, Song Y, Wang Y, Liu X, Wu Z, Chen S, Fan K, Liu Y, Zhang F, Li Z, Liu L, Zhang J, Zhang X, Ye J, Liang X, Li X, Ke X, Wu Q, Li J, Tao S, Wang X, Rosenfeld P, Heier JS, Kaiser P, Xu X. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. Br J Ophthalmol. 2022 Oct;106(10):1436-1443. doi: 10.1136/bjophthalmol-2020-318690. Epub 2021 May 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham injection | Other | Sham intravitreal injection at first month, then repeated as needed. |
|
| Laser | Procedure | Laser treatment at first month, then repeated as needed. |
|
| Sham laser | Other | Sham laser at first month, then repeated as needed. |
|
To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc. |
| 12 months |
| Change from baseline in visual acuity distribution of treatment group and controlled group | Month 6, month 12 |
| 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 |
| Peking University Third Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100083 |
| China |
|
| Beijing Tongren hospital affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| Southwest Hospital | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
|
| Daping Hospital, Research Institute of Surgery Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
|
| Zhongshan Ophthalmic Center , Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Eye hospital of Henan province | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Wuhan General Hospital of Guangzhou Military | Recruiting | Wuhan | Hubei | 430070 | China |
|
| Wuxi No.2 People's Hospital | Recruiting | Wuxi | Jiangsu | 214002 | China |
|
| He eye hospital | Recruiting | Shenyang | Liaoning | 110034 | China |
|
| Shanghai First People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
|
| Renji hospital shanghai jiaotong university school of medcine | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Xijing Hospital | Recruiting | Xian | Shanxi | 710032 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| Eye center of Tianjin mendical university | Recruiting | Tianjin | Tianjin Municipality | 300070 | China |
|
| The Affiliated Eye Hospital of WMC | Recruiting | Wenzhou | Zhejiang | 325027 | China |
|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
|
| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
| C005703 | salicylhydroxamic acid |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided