Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration

Prior treatment

• Intraocular surgery or intraocular corticosteroid treatment within 4 weeks at screening.
• Clinically significant systemic disease or infection, malignancy, prohibited concomitant treatment, prior gene therapy, or recent participation in another clinical trial.

Other illness

• Any ocular condition other than nAMD that may affect vision, study assessments, treatment safety, or interpretation of results.
• Any ocular condition making the study eye unsuitable for subretinal injection.
• Active ocular infection or inflammation, or a history of idiopathic or autoimmune uveitis.
• Any other condition considered by the investigator to make the subject unsuitable for participation.

Other

• Monocular status or non-study-eye BCVA \<19 ETDRS letters.

• Written informed consent and ability to comply with the study protocol.
• Male or female, aged 50-85 years.
• Active subfoveal MNV secondary to nAMD requiring anti-VEGF treatment.
• Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
• Study-eye BCVA of 19-78 ETDRS letters.
• Pseudophakic study eye.