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

Sponsor
Innostellar Biotherapeutics Co.,Ltd
Study ID
NCT07317934
Phase
PHASE3
Status
Recruiting
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Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)
  • Wet AMD

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 14, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Jun 4, 2032

Study Design

Enrollment
332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LX102
  • Active Comparator: Aflibercept

Primary Outcome Measure

Mean change from D0 in BCVA based on an average at weeks 40 and 48. [ Time Frame: Weeks 40 and 48 ]

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