Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD
Conditions
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 48 and 56.
Interventions
GENETICLX102
Study eyes will receive a single subretinal injection of LX102.
BIOLOGICALAflibercept
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Sponsors
Innostellar Biotherapeutics Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from D0 in BCVA based on an average at weeks 48 and 56. | Week 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with improved BCVA | Week 56 and week 104 | Proportion of participants with improved BCVA at week 56 and week 104 |
| Proportion of participants with worsened BCVA | Week 56 and week 104 | Proportion of participants with worsened BCVA at week 56 and week 104 |
| Mean change from D0 in CST based on an average at weeks 48 and 56 | Week 56 | Mean change from D0 in central subfield thickness (CST) based on an average at weeks 48 and 56 |
| Proportion of participants without SRF/IRF on OCT at week 56 | Week 56 | Proportion of participants without SRF/IRF on OCT at week 56 |
| Proportion of participants who were supplemental anti-VEGF injection-free | Through 56 weeks | Proportion of participants with no supplemental anti-VEGF injection through 56 weeks |
| Proportion of participants who received 1 or 2 aflibercept injections | Through 56 weeks | Proportion of participants received ≤2 supplemental anti-VEGF injections through 56 weeks |
| Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 56 | Through 56 weeks | Mean annualized number of anti-VEGF injections after LX102 administration through 56 weeks. |
| Incidence of ocular and nonocular AEs and SAEs | 56 weeks | Incidence of Adverse events (AE) and Serious adverse events (SAE) over 56 weeks |
| Immunogenicity characteristics of LX102 | 56 weeks | Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP) |
Countries
China
Outcome results
None listed