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| Name | Class |
|---|---|
| Shandong Boan Biotechnology Co., Ltd | INDUSTRY |
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A randomized, double-blind, parallel controlled, multicenter clinical trial to compare the efficacy and safety of LY09004 and EYLEA in the Treatment of Wet Age-related Macular Degeneration(wAMD)
This is a randomized, double-blind, parallel controlled, multicenter clinical trial.
The primary objective is to assess the efficacy similarity of LY09004 and EYLEA in the treatment of w-AMD.
The secondary objective is to assess the safety similarity of LY09004 and EYLEA in the treatment of w-AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY09004 | Experimental | LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337. |
|
| EYLEA | Active Comparator | EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY09004 | Drug | LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BCVA(best corrected visual acuity ) | Assess the BCVA change similarity from baseline of LY09004 and EYLEA | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | Assess the BCVA change similarity from baseline of LY09004 and EYLEA | week 4, week 8, week 12, week 16, week 20, week 28, week 32, week 36, week 40, week 44, week 48, week 52 |
| Letter | Proportion of subjects with 5 / 10 / 15 letters more than baseline in study eye |
| Measure | Description | Time Frame |
|---|---|---|
| AE(adverse event) | Number of patients with treatment related adverse events assessed by change from baseline. | week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youxin Chen | Contact | 8613801025972 | chenyouxinpumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Youxin Chen | Peking Union Medical College Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Eylea | Drug | EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337. |
|
| week 24, week 52 |
| Central television omentum thickness | Changes of central television omentum thickness from baseline in study eyes | week 24, week 52 |
| CNV(Choroidal neovascularization) leakage area | Changes of CNV leakage area of study eye compared with baseline | week 24, week 52 |