Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
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 STELLAR Trial
Innostellar Biotherapeutics Co.,Ltd
332 participants
Jan 14, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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;
- Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
- No anti-VEGF therapy in study eye within 28 days before screening;
- Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).
Exclusion Criteria10
- 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;
- History of idiopathic or autoimmune uveitis in either eye;
- Advanced glaucoma in the study eye;
- History of vitrectomy surgery in the study eye;
- History of intraocular surgery within 1 month before screening in the study eye;
- History of ocular or systemic gene therapy;
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
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Interventions
Study eyes will receive a single subretinal injection of LX102.
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Locations(31)
View Full Details on ClinicalTrials.gov
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NCT07317934