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

Phase 3RecruitingNCT07317934

Innostellar Biotherapeutics Co.,Ltd388 enrolled

Overview

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 48 and 56.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

388

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)Wet AMD

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. 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 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.

Locations (36)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

Beijing Aier-Intech Eye Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Mean change from D0 in BCVA based on an average at weeks 48 and 56.

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 48 and 56.

Time frame: Week 56

Secondary Outcomes

Proportion of participants with improved BCVA

Proportion of participants with improved BCVA at week 56 and week 104

Time frame: Week 56 and week 104

Proportion of participants with worsened BCVA

Proportion of participants with worsened BCVA at week 56 and week 104

Time frame: Week 56 and week 104

Mean change from D0 in CST based on an average at weeks 48 and 56

Mean change from D0 in central subfield thickness (CST) based on an average at weeks 48 and 56

Time frame: Week 56

Proportion of participants without SRF/IRF on OCT at week 56

Time frame: Week 56

Proportion of participants who were supplemental anti-VEGF injection-free

Proportion of participants with no supplemental anti-VEGF injection through 56 weeks

Time frame: Through 56 weeks

Proportion of participants who received 1 or 2 aflibercept injections

Proportion of participants received ≤2 supplemental anti-VEGF injections through 56 weeks

Time frame: Through 56 weeks

Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 56

Mean annualized number of anti-VEGF injections after LX102 administration through 56 weeks.

Time frame: Through 56 weeks

Incidence of ocular and nonocular AEs and SAEs

Incidence of Adverse events (AE) and Serious adverse events (SAE) over 56 weeks

Time frame: 56 weeks

Immunogenicity characteristics of LX102

Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP)

Time frame: 56 weeks