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

NCT07317934 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

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

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.

Sponsors & Collaborators

  • Innostellar Biotherapeutics Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2028-03-31
Completion
2032-06-04

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317934 on ClinicalTrials.gov