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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-80
SponsorInnostellar Biotherapeutics Co.,Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Willing and able to provide written, signed informed consent for this study;

Age ≥50 and ≤80 years old;

active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;

The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;

Disqualifiers

Any condition in the investigator's opinion that could limit VA improvement in the study eye.

CNV or macular edema in the study eye secondary to any causes other than AMD

Subfoveal fibrosis or atrophy in the study eye, as determined by CRC;

History of retinal detachment in the study eye at any time;

Trial design

Treatments tested in this trial

  • LX102
  • Aflibercept

Treatment groups

332 Participants
are divided into 2 treatment groups