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Clinical Trials in China / NCT07317934
Recruiting Phase 3

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

NCT07317934 · tracked via the Priya Life Science China tracker
Sponsor
Innostellar Biotherapeutics Co.,Ltd
Phase
Phase 3
Started
2026-01-14
Last updated
2026-08-06

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD)Wet AMD

Investigational drug(s) / intervention(s)

LX102Aflibercept

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.

Study 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 48 and 56.

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Willing and able to provide written, signed informed consent for this study; 2. Age ≥50 and ≤80 years old; 3. Active CNV secondary to nAMD in the study eye confirmed by FFA or OCT; 4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening; 5. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center; 6. No anti-VEGF therapy in study eye within 28 days before screening; 7. Must be pseudophakic in the study eye. Exclusion Criteria: 1. Any condition in the investigator's opinion that could limit VA improvement in the study eye. 2. CNV or macular edema in the study eye secondary to any causes other than AMD 3. Subfoveal atrophy in the study eye, as determined by CRC; 4. History of retinal detachment in the study eye at any time; 5. History of idiopathic or autoimmune uveitis in either eye; 6. Advanced glaucoma in the study eye; 7. History of vitrectomy surgery in the study eye; 8. History of intraocular surgery within 1 month before screening in the study eye; 9. History of ocular or systemic gene therapy; 10. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui Recruiting
Beijing Aier-Intech Eye Hospital Beijing Beijing Municipality Recruiting
Beijing Hospital Beijing Beijing Municipality Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Southwest Hospital Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Jinan University Guangzhou Guangdong Recruiting
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong Shantou Guangdong Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University Zhongshan Guangdong Recruiting
Hebei Eye Hospital Xingtai Hebei Recruiting
The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
Tongji Hospital Tongji Medical College of HUST Wuhan Hubei Recruiting
Central Theater Command General Hospital of PLA Wuhan Hubei Recruiting
The Second Xiangya Hospital, Central South University Changsha Hunan Recruiting
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital Changsha Hunan Recruiting
The Affiliated Eye Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
Xuzhou First People's Hospital Xuzhou Jiangsu Recruiting
The Second Hospital of Jilin University Changchun Jilin Recruiting
Shenyang Fourth People's Hospital Shenyang Liaoning Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shandong Eye Hospital Jinan Shandong Recruiting
Qingdao Eye Hospital Affiliated to Shandong First Medical University Qingdao Shandong Recruiting
Eye & ENT Hospital of Fudan University Shanghai Shanghai Municipality Recruiting
Shanghai General Hospital Shanghai Shanghai Municipality Recruiting
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Recruiting
Shanxi Eye Hospital Taiyuan Shanxi Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Recruiting
Xi 'an People's Hospital (Xi 'an No.4 Hospital) Xi’an Shanxi Recruiting
The First Affiliated Hospital of Air Force Medical University Xi’an Shanxi Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Recruiting
Tianjin Eye Hospital Tianjin Tianjin Municipality Recruiting
Tianjin Medical University Eye Hospital Tianjin Tianjin Municipality Recruiting
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Recruiting
The Eye Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting

More Innostellar Biotherapeutics Co.,Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07317934 on ClinicalTrials.gov ↗ ← All trials in China