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

Sponsor
Innostellar Biotherapeutics Co.,Ltd
Study ID
NCT06196840
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • LX102 subretinal injection — GENETIC
    LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
  • Aflibercept intravitreal injection — BIOLOGICAL
    Commercially available Active Comparator

Study Details

The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

Key Dates

Start date
Jan 24, 2024
Status verified
Mar 2026
Primary completion
Jun 24, 2025
Completion
Oct 31, 2029

Study Design

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

Arms

  • Experimental: LX102 Dose 1
    LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0
  • Experimental: LX102 Dose 2
    LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0
  • Active Comparator: Control group
    Aflibercept at a fixed regimen will be administered.

Primary Outcome Measure

Mean change from baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: 36 weeks ]

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