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NCT07776522
Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration
Conditions: Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
Sex: All
Ages: 50 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: West China Hospital
Location: Beijing Hospital Beijing Beijing Municipality
Summary
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07776522). StuddyBuddy aggregates publicly available trial information.