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

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.

Study Overview

• Status: Recruiting
• Conditions: Wet AMD; Neovascular Age-Related Macular Degeneration (nAMD)
• Intervention / Treatment: Genetic: LX102; Biological: Aflibercept

• Study Type: Interventional
• Enrollment (Estimated): 332
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Not yet recruiting
      • The First Affiliated Hospital of University of Science and Technology of China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Not yet recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Not yet recruiting
      • Beijing Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400010
      • Not yet recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510632
      • Not yet recruiting
      • The First Affiliated Hospital of Jinan University
    • Shantou, Guangdong, China, 515041
      • Not yet recruiting
      • Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
    • Zhongshan, Guangdong, China, 510623
      • Not yet recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: professor; Phone Number: 020-66610720; Email: zoccrc@mail.sysu.edu.cn
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Not yet recruiting
      • The Second Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Not yet recruiting
      • Central Theater Command General Hospital of PLA
  • Hunan
    • Changsha, Hunan, China, 410011
      • Not yet recruiting
      • The Second Xiangya Hospital, Central South University
    • Changsha, Hunan, China, 410015
      • Not yet recruiting
      • Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Not yet recruiting
      • The Affiliated Eye Hospital of Nanjing Medical University
    • Xuzhou, Jiangsu, China, 221002
      • Not yet recruiting
      • Xuzhou First People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130022
      • Not yet recruiting
      • The Second Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Not yet recruiting
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250021
      • Not yet recruiting
      • Shandong Eye Hospital
    • Qingdao, Shandong, China, 266071
      • Not yet recruiting
      • Qingdao Eye Hospital Affiliated to Shandong First Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Recruiting
      • Shanghai General Hospital
      • Contact: associate professor; Phone Number: 021-36126255; Email: shiyigcp@126.com
    • Shanghai, Shanghai Municipality, China, 200031
      • Not yet recruiting
      • Eye & ENT Hospital of Fudan University
    • Shanghai, Shanghai Municipality, China, 200092
      • Not yet recruiting
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai Municipality, China, 201801
      • Not yet recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Not yet recruiting
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China, 030002
      • Not yet recruiting
      • Shanxi eye hospital
    • Xi’an, Shanxi, China, 710004
      • Not yet recruiting
      • Xi 'an People's Hospital (Xi 'an No.4 Hospital)
    • Xi’an, Shanxi, China, 710032
      • Not yet recruiting
      • The First Affiliated Hospital of Air Force Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Not yet recruiting
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 646100
      • Not yet recruiting
      • Sichuan Provincial People's Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300384
      • Recruiting
      • Tianjin Medical University Eye Hospital
      • Contact: professor; Phone Number: 022-86428810; Email: zoccrc@mail.sysu.edu.cn
    • Tianjin, Tianjin Municipality, China, 300020
      • Not yet recruiting
      • Tianjin Eye Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Not yet recruiting
      • Zhejiang Provincial People's Hospital
    • Wenzhou, Zhejiang, China, 325027
      • Not yet recruiting
      • The Eye Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 (at least 4 weeks after cataract surgery).

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 fibrosis or 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aflibercept	Biological: Aflibercept; Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Experimental: LX102	Genetic: LX102; Study eyes will receive a single subretinal injection of LX102.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from D0 in BCVA based on an average at weeks 40 and 48.	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 40 and 48.	Weeks 40 and 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with improved BCVA	Proportion of participants with improved BCVA at week 48	Week 48
Proportion of participants with worsened BCVA	Proportion of participants with worsened BCVA at week 48	Week 48
Mean change from D0 in CST based on an average at weeks 40 and 48	Mean change from D0 in central subfield thickness (CST) based on an average at weeks 40 and 48	Weeks 40 and 48
Proportion of participants without SRF/IRF on OCT at week 48	Proportion of participants without SRF/IRF on OCT at week 48	Week 48
Proportion of participants who were supplemental anti-VEGF injection-free	Proportion of participants with no supplemental anti-VEGF injection through 48 weeks	Through 48 weeks
Proportion of participants who received 1 or 2 aflibercept injections	Proportion of participants received ≤2 supplemental anti-VEGF injections through 48 weeks	Through 48 weeks
Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 48	Mean annualized number of anti-VEGF injections after LX102 administration through 48 weeks.	Through 48 weeks
Incidence of ocular and nonocular AEs and SAEs	Incidence of Adverse events (AE) and Serious adverse events (SAE) over 48 weeks	48 weeks
Immunogenicity characteristics of LX102	Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP)	48 weeks

Collaborators and Investigators

• Sponsor: Innostellar Biotherapeutics Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 4, 2032

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: aflibercept
• Other Study ID Numbers: INNOSTELLAR-LX102A03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No