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Clinical Trials in China / NCT07776522
Recruiting Phase 2

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

NCT07776522 · tracked via the Priya Life Science China tracker
Sponsor
West China Hospital
Phase
Phase 2
Started
2026-08-31
Last updated
2026-08-20

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

Investigational drug(s) / intervention(s)

JWK001Aflibercept (2.0 mg)

JWK001: JWK001 will be administered as a single subretinal injection in one study eye.

Aflibercept (2.0 mg): Aflibercept 2 mg will be administered by intravitreal injection at Weeks 2, 10, 18, 26, 34, 42, and 50 after randomization, for a total of seven injections.

Study 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

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Beijing Hospital Beijing Beijing Municipality Recruiting
Peking University People's Hospital Beijing Beijing Municipality Not Yet Recruiting
The Second Hospital of Jilin University Jilin City Changchun Not Yet Recruiting
Southwest Hospital, Army Medical University(Southwest Hospital) Chongqing Chongqing Municipality Not Yet Recruiting
Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong Shantou Guangdong Not Yet Recruiting
Zhejiang Provincial People's Hospital Zhejiang Hangzhou Not Yet Recruiting
The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
General Hospital of Central Theater Command, Chinese People's Liberation Army Wuhan Hubei Not Yet Recruiting
Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu Not Yet Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Not Yet Recruiting
Shanxi Eye Hospital Taiyuan Shanxi Not Yet Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Tianjin Eye Hospital Tianjin Tianjin Municipality Not Yet Recruiting
The First People's Hospital of Yunnan Province Kunming Yunnan Not Yet Recruiting

More West China Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07776522 on ClinicalTrials.gov ↗ ← All trials in China