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Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
Sponsor: Innostellar Biotherapeutics Co.,Ltd
Summary
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.
Official title: 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 STELLAR Trial
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
332
Start Date
2026-01-14
Completion Date
2032-06-04
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
LX102
Study eyes will receive a single subretinal injection of LX102.
Aflibercept
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Locations (31)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Zhongshan, Guangdong, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Central Theater Command General Hospital of PLA
Wuhan, Hubei, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
Changsha, Hunan, China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Xuzhou First People's Hospital
Xuzhou, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Eye Hospital
Jinan, Shandong, China
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Qingdao, Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Xi 'an People's Hospital (Xi 'an No.4 Hospital)
Xi’an, Shanxi, China
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China