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

A Phase II Study to Evaluate the Safety and Preliminary Efficacy of Subretinal Administration of JWK001 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

This is a Phase II, randomized, open-label, active-controlled study designed to evaluate the preliminary efficacy and safety of a single subretinal administration of JWK001 at different dose levels in patients with neovascular age-related macular degeneration.

Inclusion Criteria:

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

Exclusion Criteria:

1. Any ocular condition other than nAMD that may affect vision, study assessments, treatment safety, or interpretation of results.
2. Intraocular surgery or intraocular corticosteroid treatment within 4 weeks at screening.
3. Any ocular condition making the study eye unsuitable for subretinal injection.
4. Active ocular infection or inflammation, or a history of idiopathic or autoimmune uveitis.
5. Monocular status or non-study-eye BCVA <19 ETDRS letters.
6. Clinically significant systemic disease or infection, malignancy, prohibited concomitant treatment, prior gene therapy, or recent participation in another clinical trial.
7. Any other condition considered by the investigator to make the subject unsuitable for participation.