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

Innostellar Biotherapeutics

Status and phase: Not yet enrolling; Phase 3

Conditions: Wet AMD; Neovascular Age-Related Macular Degeneration (nAMD)

Treatments: Genetic: LX102; Biological: Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT07317934

INNOSTELLAR-LX102A03

Details and patient eligibility

About

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.

Enrollment: 332 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to provide written, signed informed consent for this study;
2. Age ≥50 and ≤80 years old;
3. active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
5. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
6. No anti-VEGF therapy in study eye within 28 days before screening;
7. Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).

Exclusion criteria

1. Any condition in the investigator's opinion that could limit VA improvement in the study eye.
2. CNV or macular edema in the study eye secondary to any causes other than AMD
3. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC;
4. History of retinal detachment in the study eye at any time;
5. History of idiopathic or autoimmune uveitis in either eye;
6. Advanced glaucoma in the study eye;
7. History of vitrectomy surgery in the study eye;
8. History of intraocular surgery within 1 month before screening in the study eye;
9. History of ocular or systemic gene therapy;
10. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

LX102

Experimental group

Treatment:

Genetic: LX102

Aflibercept

Active Comparator group

Treatment:

Biological: Aflibercept