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

August 4, 2026 updated by: Innostellar Biotherapeutics Co.,Ltd

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 48 and 56.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

388

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100000
        • Recruiting
        • Beijing Aier-Intech Eye Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510632
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Contact:
      • Shantou, Guangdong, China, 515041
        • Recruiting
        • Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
        • Contact:
      • Zhongshan, Guangdong, China, 510623
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
    • Hebei
      • Xingtai, Hebei, China, 054000
        • Recruiting
        • Hebei Eye Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical College of HUST
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Central Theater Command General Hospital of PLA
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital, Central South University
        • Contact:
      • Changsha, Hunan, China, 410015
        • Recruiting
        • Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The Affiliated Eye Hospital of Nanjing Medical University
        • Contact:
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • Xuzhou First People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130022
        • Recruiting
        • the Second Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang Fourth People's Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Eye Hospital
        • Contact:
      • Qingdao, Shandong, China, 266071
        • Recruiting
        • Qingdao Eye Hospital Affiliated to Shandong First Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Recruiting
        • Eye & ENT Hospital of Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, China, 201801
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Taiyuan, Shanxi, China, 030002
        • Recruiting
        • Shanxi Eye Hospital
        • Contact:
      • Xi’an, Shanxi, China, 710032
        • Recruiting
        • The First Affiliated Hospital of Air Force Medical University
        • Contact:
      • Xi’an, Shanxi, China, 710004
        • Recruiting
        • Xi 'an People's Hospital (Xi 'an No.4 Hospital)
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, Sichuan, China, 646100
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300384
        • Recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Tianjin Eye Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Eye Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 48 and 56.
Time Frame: Week 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with improved BCVA
Time Frame: Week 56 and week 104
Proportion of participants with improved BCVA at week 56 and week 104
Week 56 and week 104
Proportion of participants with worsened BCVA
Time Frame: Week 56 and week 104
Proportion of participants with worsened BCVA at week 56 and week 104
Week 56 and week 104
Mean change from D0 in CST based on an average at weeks 48 and 56
Time Frame: Week 56
Mean change from D0 in central subfield thickness (CST) based on an average at weeks 48 and 56
Week 56
Proportion of participants without SRF/IRF on OCT at week 56
Time Frame: 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
Time Frame: Through 56 weeks
Proportion of participants with no supplemental anti-VEGF injection through 56 weeks
Through 56 weeks
Proportion of participants who received 1 or 2 aflibercept injections
Time Frame: Through 56 weeks
Proportion of participants received ≤2 supplemental anti-VEGF injections through 56 weeks
Through 56 weeks
Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 56
Time Frame: Through 56 weeks
Mean annualized number of anti-VEGF injections after LX102 administration through 56 weeks.
Through 56 weeks
Incidence of ocular and nonocular AEs and SAEs
Time Frame: 56 weeks
Incidence of Adverse events (AE) and Serious adverse events (SAE) over 56 weeks
56 weeks
Immunogenicity characteristics of LX102
Time Frame: 56 weeks
Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP)
56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innostellar Biotherapeutics Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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