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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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