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NCT Number: NCT07317934

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration (nAMD) Wet AMD

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 (at least 4 weeks after cataract surgery).

Exclusion criteria

  • 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 fibrosis or 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.

Treatment and study plan

LX102

Genetic

Study eyes will receive a single subretinal injection of LX102.

Aflibercept

Biological

Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.

Primary outcomes

  1. Mean change from D0 in BCVA based on an average at weeks 40 and 48.

    Time frame: 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.

Secondary outcomes

  1. Proportion of participants with improved BCVA

    Time frame: Week 48

    Proportion of participants with improved BCVA at week 48

  2. Proportion of participants with worsened BCVA

    Time frame: Week 48

    Proportion of participants with worsened BCVA at week 48

  3. Mean change from D0 in CST based on an average at weeks 40 and 48

    Time frame: Weeks 40 and 48

    Mean change from D0 in central subfield thickness (CST) based on an average at weeks 40 and 48

  4. Proportion of participants without SRF/IRF on OCT at week 48

    Time frame: Week 48

    Proportion of participants without SRF/IRF on OCT at week 48

  5. Proportion of participants who were supplemental anti-VEGF injection-free

    Time frame: Through 48 weeks

    Proportion of participants with no supplemental anti-VEGF injection through 48 weeks

  6. Proportion of participants who received 1 or 2 aflibercept injections

    Time frame: Through 48 weeks

    Proportion of participants received ≤2 supplemental anti-VEGF injections through 48 weeks

  7. Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 48

    Time frame: Through 48 weeks

    Mean annualized number of anti-VEGF injections after LX102 administration through 48 weeks.

  8. Incidence of ocular and nonocular AEs and SAEs

    Time frame: 48 weeks

    Incidence of Adverse events (AE) and Serious adverse events (SAE) over 48 weeks

  9. Immunogenicity characteristics of LX102

    Time frame: 48 weeks

    Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP)

Sponsors and collaborators

Lead sponsor

Innostellar Biotherapeutics Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Jan 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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