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
1 other identifier
interventional
388
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
Longer than P75 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2025
CompletedFirst Posted
Study publicly available on registry
January 5, 2026
CompletedStudy Start
First participant enrolled
January 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 4, 2032
August 6, 2026
August 1, 2026
2.1 years
December 19, 2025
August 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from D0 in BCVA based on an average at weeks 48 and 56.
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 48 and 56.
Week 56
Secondary Outcomes (9)
Proportion of participants with improved BCVA
Week 56 and week 104
Proportion of participants with worsened BCVA
Week 56 and week 104
Mean change from D0 in CST based on an average at weeks 48 and 56
Week 56
Proportion of participants without SRF/IRF on OCT at week 56
Week 56
Proportion of participants who were supplemental anti-VEGF injection-free
Through 56 weeks
- +4 more secondary outcomes
Study Arms (2)
LX102
EXPERIMENTALAflibercept
ACTIVE COMPARATORInterventions
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any condition in the investigator's opinion that could limit VA improvement in the study eye.
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal atrophy in the study eye, as determined by CRC;
- History of retinal detachment in the study eye at any time;
- History of idiopathic or autoimmune uveitis in either eye;
- Advanced glaucoma in the study eye;
- History of vitrectomy surgery in the study eye;
- History of intraocular surgery within 1 month before screening in the study eye;
- History of ocular or systemic gene therapy;
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230601, China
Beijing Aier-Intech Eye Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510632, China
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, 515041, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Zhongshan, Guangdong, 510623, China
Hebei Eye Hospital
Xingtai, Hebei, 054000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Central Theater Command General Hospital of PLA
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011, China
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
Changsha, Hunan, 410015, China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Xuzhou First People's Hospital
Xuzhou, Jiangsu, 221002, China
The Second Hospital of Jilin University
Changchun, Jilin, 130022, China
Shenyang Fourth People's Hospital
Shenyang, Liaoning, 110000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Eye Hospital
Jinan, Shandong, 250021, China
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Qingdao, Shandong, 266071, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 201801, China
Shanxi Eye Hospital
Taiyuan, Shanxi, 030002, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Xi 'an People's Hospital (Xi 'an No.4 Hospital)
Xi’an, Shanxi, 710004, China
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 646100, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2025
First Posted
January 5, 2026
Study Start
January 14, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
June 4, 2032
Last Updated
August 6, 2026
Record last verified: 2026-08