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Recruiting NCT07317934

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

Phase III Interventional Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LX102, Aflibercept.
Who it may be relevant to
Registry conditions: Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Genetic LX102
    Study eyes will receive a single subretinal injection of LX102.
  • Biological Aflibercept
    Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.

Primary outcome measures

  • Mean change from D0 in BCVA based on an average at weeks 48 and 56. [Time frame: Week 56]
Secondary outcome measures (9)
  • Proportion of participants with improved BCVA [Time frame: Week 56 and week 104]
  • Proportion of participants with worsened BCVA [Time frame: Week 56 and week 104]
  • Mean change from D0 in CST based on an average at weeks 48 and 56 [Time frame: Week 56]
  • Proportion of participants without SRF/IRF on OCT at week 56 [Time frame: Week 56]
  • Proportion of participants who were supplemental anti-VEGF injection-free [Time frame: Through 56 weeks]
  • Proportion of participants who received 1 or 2 aflibercept injections [Time frame: Through 56 weeks]
  • Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 56 [Time frame: Through 56 weeks]
  • Incidence of ocular and nonocular AEs and SAEs [Time frame: 56 weeks]
  • Immunogenicity characteristics of LX102 [Time frame: 56 weeks]

Eligibility criteria

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.

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 36 centers
  • The First Affiliated Hospital of University of Science and Technology of China — Hefei
  • Beijing Aier-Intech Eye Hospital — Beijing
  • Beijing Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • The Second Affiliated Hospital of Chongqing Medical University — Chongqing
  • Southwest Hospital — Chongqing
  • The First Affiliated Hospital of Jinan University — Guangzhou
  • Joint Shantou International Eye Center, Shantou University and the Chinese University of H — Shantou
  • … and 28 more centers

Identifiers

NCT: NCT07317934 · INNOSTELLAR-LX102A03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗