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This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conbercept treatment group | Experimental | Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results. |
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| sham injection group | Sham Comparator | Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conbercept, Fixed | Drug | intravitreal injection of 0.5 mg conbercept per month, fixed injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean change from baseline of visual acuity | to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3 | 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| mean change from baseline of anatomical features | to compare the difference of mean change from baseline of CRT, CNV size and lesion size between conbercept treatment group and sham injection group at month 3 | 3-month |
| mean change from baseline of visual acuity |
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Inclusion Criteria:
Patients give fully informed consent and are willing and able to comply with all study procedures.
In the study eye:
The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China | ||
| Peking University Third Hospital |
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| conbercept, PRN | Drug | intravitreal injection of 0.5 mg conbercept as need, PRN |
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| sham injection | Other | sham intravitreal injection per month, fixed injection |
|
to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9 |
| 9 months |
| safety and tolerability of conbercept | to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9 | 3-month and 9-month |
| Beijing |
| Beijing Municipality |
| 100083 |
| China |
| Beijing Tongren hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| Southwest Hospital | Chongqing | Chongqing Municipality | 400038 | China |
| Daping Hospital, Research Institute of Surgery Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | 510060 | China |
| Wuhan General Hospital of Guangzhou Military | Wuhan | Hubei | 430070 | China |
| Wuxi No.2 People's Hospital | Wuxi | Jiangsu | 214002 | China |
| Ophthalmologic Hospital of Qingdao | Qingdao | Shandong | 266071 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Xijing Hospital | Xian | Shanxi | 710032 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| The Affiliated Eye Hospital of WMC | Wenzhou | Zhejiang | 325027 | China |
| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
| C005703 | salicylhydroxamic acid |
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