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

RecruitingPhase 2Ages 50 Years - 85 YearsAllWest China Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • JWK001
  • Aflibercept (2.0 mg)
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Where

16 sites
Beijing Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Hospital of Jilin University
Jilin City, China
Southwest Hospital, Army Medical University(Southwest Hospital)
Chongqing, China
Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, China
Zhejiang Provincial People's Hospital
Zhejiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Henan Provincial People's Hospital
Zhengzhou, China

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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