NCT07317934
Recruiting
Phase 3
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.,Ltd31 sites in 1 country332 target enrollmentStarted: January 14, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Innostellar Biotherapeutics Co.,Ltd
- Enrollment
- 332
- Locations
- 31
- Primary Endpoint
- Mean change from D0 in BCVA based on an average at weeks 40 and 48.
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
LX102
Experimental
Intervention: LX102 (Genetic)
Aflibercept
Active Comparator
Intervention: Aflibercept (Biological)
Outcomes
Primary Outcomes
Mean change from D0 in BCVA based on an average at weeks 40 and 48.
Time Frame: Weeks 40 and 48
Mean change from D0 in BCVA as measured by the early treatment diabetic retinopathy study (ETDRS) visual acuity chart based on an average at weeks 40 and 48.
Secondary Outcomes
- Proportion of participants with improved BCVA(Week 48)
- Proportion of participants with worsened BCVA(Week 48)
- Mean change from D0 in CST based on an average at weeks 40 and 48(Weeks 40 and 48)
- Proportion of participants without SRF/IRF on OCT at week 48(Week 48)
- Proportion of participants who were supplemental anti-VEGF injection-free(Through 48 weeks)
- Proportion of participants who received 1 or 2 aflibercept injections(Through 48 weeks)
- Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 48(Through 48 weeks)
- Incidence of ocular and nonocular AEs and SAEs(48 weeks)
- Immunogenicity characteristics of LX102(48 weeks)
Investigators
Study Sites (31)
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