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  4. 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

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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

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Biological, Genetic
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Willing and able to provide written, signed informed consent for this study;

• Age ≥50 and ≤80 years old;

• active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;

• The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;

• Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;

• No anti-VEGF therapy in study eye within 28 days before screening;

• Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).

Locations
Other Locations
China
Beijing Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital, Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Jinan University
NOT_YET_RECRUITING
Guangzhou
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of University of Science and Technology of China
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Eye Hospital
NOT_YET_RECRUITING
Jinan
The Affiliated Eye Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Qingdao Eye Hospital Affiliated to Shandong First Medical University
NOT_YET_RECRUITING
Qingdao
Eye & ENT Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
NOT_YET_RECRUITING
Shantou
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Shanxi Eye Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Eye Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
The Eye Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Central Theater Command General Hospital of PLA
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITING
Xi’an
Xi 'an People's Hospital (Xi 'an No.4 Hospital)
NOT_YET_RECRUITING
Xi’an
Xuzhou First People's Hospital
NOT_YET_RECRUITING
Xuzhou
Zhongshan Ophthalmic Center, Sun Yat-sen University
NOT_YET_RECRUITING
Zhongshan
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2032-06-04
Participants
Target number of participants: 332
Treatments
Experimental: LX102
Active_comparator: Aflibercept
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Innostellar Biotherapeutics Co.,Ltd

This content was sourced from clinicaltrials.gov

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