RecruitingPhase 3NCT07317934

Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)

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

Sponsor

Innostellar Biotherapeutics Co.,Ltd

Enrollment

332 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)Wet AMD

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Aflibercept and LX102 for people with neovascular age-related macular degeneration (namd) and wet amd. The study is currently recruiting participants at 31 locations. People eligible for this study include aged 50 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICLX102

Study eyes will receive a single subretinal injection of LX102.

BIOLOGICALAflibercept

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

View Full Details on ClinicalTrials.gov

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NCT07317934

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