Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06198413

LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

Loading trial locations.

About this study

This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.

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
  • Diagnosis of active CNV secondary to neovascular AMD
  • BCVA ETDRS letters between 5 and 63
  • Subjects must have received a minimum of 2 injections within 6 months prior to screening
  • 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
  • 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 >7.5%

Treatment and study plan

LX102 subretinal injection

Genetic

LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Time frame: 4 weeks

    Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses

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

    Time frame: 52 weeks

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

Secondary outcomes

  1. Mean change in BCVA from Baseline

    Time frame: 12 weeks, 36 weeks 52 weeks

    BCVA measured by ETDRS

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

    Time frame: 12 weeks, 36 weeks 52 weeks

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

  3. Mean time from LX102 administration to anti-VEGF rescue injection for the first time

    Time frame: 52 weeks

  4. Percentage of participants requiring anti-VEGF rescue injection

    Time frame: 52 weeks

  5. Mean number of anti-VEGF rescue injections

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Innostellar Biotherapeutics Co.,Ltd

Industry

Registry information

Official study title

A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)

Important dates

Study start
2023
Primary completion
2024
Study completion
2029
First posted
Jan 10, 2024
Registry last updated
Jul 1, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.