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This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 40 and 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX102 | Experimental |
| |
| Aflibercept | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX102 | Genetic | Study eyes will receive a single subretinal injection of LX102. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from D0 in BCVA based on an average at weeks 40 and 48. | Mean change from D0 in BCVA as measured by the early treatment diabetic retinopathy study (ETDRS) visual acuity chart based on an average at weeks 40 and 48. | Weeks 40 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with improved BCVA | Proportion of participants with improved BCVA at week 48 | Week 48 |
| Proportion of participants with worsened BCVA | Proportion of participants with worsened BCVA at week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Not yet recruiting | Hefei | Anhui | 230601 | China |
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| Aflibercept |
| Biological |
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks. |
|
| Week 48 |
| Mean change from D0 in CST based on an average at weeks 40 and 48 | Mean change from D0 in central subfield thickness (CST) based on an average at weeks 40 and 48 | Weeks 40 and 48 |
| Proportion of participants without SRF/IRF on OCT at week 48 | Proportion of participants without SRF/IRF on OCT at week 48 | Week 48 |
| Proportion of participants who were supplemental anti-VEGF injection-free | Proportion of participants with no supplemental anti-VEGF injection through 48 weeks | Through 48 weeks |
| Proportion of participants who received 1 or 2 aflibercept injections | Proportion of participants received ≤2 supplemental anti-VEGF injections through 48 weeks | Through 48 weeks |
| Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 48 | Mean annualized number of anti-VEGF injections after LX102 administration through 48 weeks. | Through 48 weeks |
| Incidence of ocular and nonocular AEs and SAEs | Incidence of Adverse events (AE) and Serious adverse events (SAE) over 48 weeks | 48 weeks |
| Immunogenicity characteristics of LX102 | Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP) | 48 weeks |
| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
| The First Affiliated Hospital of Jinan University | Not yet recruiting | Guangzhou | Guangdong | 510632 | China |
| Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong | Not yet recruiting | Shantou | Guangdong | 515041 | China |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Not yet recruiting | Zhongshan | Guangdong | 510623 | China |
|
| The Second Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
| Central Theater Command General Hospital of PLA | Not yet recruiting | Wuhan | Hubei | 430060 | China |
| The Second Xiangya Hospital, Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
| Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital | Not yet recruiting | Changsha | Hunan | 410015 | China |
| The Affiliated Eye Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
| Xuzhou First People's Hospital | Not yet recruiting | Xuzhou | Jiangsu | 221002 | China |
| The Second Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130022 | China |
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
| Shandong Eye Hospital | Not yet recruiting | Jinan | Shandong | 250021 | China |
| Qingdao Eye Hospital Affiliated to Shandong First Medical University | Not yet recruiting | Qingdao | Shandong | 266071 | China |
| Eye & ENT Hospital of Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200031 | China |
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
|
| Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 201801 | China |
| Shanxi Eye Hospital | Not yet recruiting | Taiyuan | Shanxi | 030002 | China |
| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
| Xi 'an People's Hospital (Xi 'an No.4 Hospital) | Not yet recruiting | Xi’an | Shanxi | 710004 | China |
| The First Affiliated Hospital of Air Force Medical University | Not yet recruiting | Xi’an | Shanxi | 710032 | China |
| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 646100 | China |
| Tianjin Eye Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300384 | China |
|
| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310014 | China |
| The Eye Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325027 | China |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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