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)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
West China Hospital, Sichuan University
RECRUITING
Chengdu
Southwest Hospital, Army Medical University（Southwest Hospital）
NOT_YET_RECRUITING
Chongqing
The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Jilin City
The First People's Hospital of Yunnan Province
NOT_YET_RECRUITING
Kunming
Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
NOT_YET_RECRUITING
Shantou
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Shanxi Eye Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Eye Hospital
NOT_YET_RECRUITING
Tianjin
General Hospital of Central Theater Command, Chinese People's Liberation Army
NOT_YET_RECRUITING
Wuhan
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Zhejiang
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Lu
lufang@wchscu.cn
86-0288542538
Time Frame
Start Date: 2026-08-31
Estimated Completion Date: 2032-01-14
Participants
Target number of participants: 50
Treatments
Experimental: JWK001 3×10^10 vg/eye group
Participants assigned to this arm will receive a single subretinal injection of JWK001 at a dose of 3 × 10\^10 vector genomes (vg) in one study eye.
Experimental: JWK001 6×10^10 vg/eye group
Participants assigned to this arm will receive a single subretinal injection of JWK001 at a dose of 6 × 10\^10 vector genomes (vg) in one study eye.
Active_comparator: Aflibercept Active Comparator Group
Participants assigned to this arm will receive aflibercept 2 mg by intravitreal injection at Weeks 2, 10, 18, 26, 34, 42, and 50 after randomization.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital