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NCT Number: NCT06196840

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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About this study

In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).

Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to sign the informed consent, and willing to attend follow-up visits.
  • Age ≥ 50, and ≤ 89.
  • Diagnosis of active CNV secondary to neovascular AMD.
  • BCVA ETDRS letters between 19 and 73.
  • Demonstrated a meaningful response to anti-VEGF therapy.

Exclusion criteria

  • CNV or macular edema in the study eye secondary to diseases other than nAMD.
  • Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement.
  • Absence of RPE tear at Screening.
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months.
  • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg.
  • Uncontrolled diabetes defined as HbA1c >8.0%.

Treatment and study plan

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

Primary outcomes

  1. Mean change from baseline in Best Corrected Visual Acuity (BCVA)

    Time frame: 36 weeks

    BCVA measured by ETDRS

Secondary outcomes

  1. Mean change from baseline in Best Corrected Visual Acuity (BCVA)

    Time frame: 52 weeks

    BCVA measured by ETDRS

  2. Mean change in Central Subfield Thickness (CST) from Baseline

    Time frame: 36 weeks, 52 weeks

    CST measured by spectral domain optical coherence tomography (SD-OCT)

  3. Durability of LX102 treatment

    Time frame: 52 weeks

    Mean time from LX102 administration to anti-VEGF rescue injection for the first time, percentage of participants requiring anti-VEGF rescue injection, and mean number of anti-VEGF rescue injections through 52 weeks following LX102 administration.

  4. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 36 weeks, 52 weeks

    Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection

Sponsors and collaborators

Lead sponsor

Innostellar Biotherapeutics Co.,Ltd

Industry

Registry information

Official study title

A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jan 9, 2024
Registry last updated
Mar 6, 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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