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.
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;
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 atrophy in the study eye, as determined by CRC;
History of retinal detachment in the study eye at any time;
Parallel
LX102
GeneticStudy eyes will receive a single subretinal injection of LX102.
Aflibercept
Biological/VaccineStudy eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
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.
Proportion of participants with improved BCVA
Proportion of participants with improved BCVA at week 56 and week 104
Proportion of participants with worsened BCVA
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
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
Proportion of participants without SRF/IRF on OCT at week 56
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