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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
JWK001 will be administered as a single subretinal injection in one study eye.
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.
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange from baseline in best-corrected visual acuity (BCVA)
BCVA measured via the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Time frame: Week 34
Change from baseline in BCVA
BCVA measured via the ETDRS letter score
Time frame: Week 50 and Year 5
Change from baseline in central retinal thickness (CRT)
Time frame: Week 34, Week 50 and Year 5
Change from baseline in the area of Macular Neovascularization (MNV)
MNV measured via Fluorescein Angiography (FFA)
Time frame: Week 34 and Week 50
Change from baseline in leakage area
Leakage area assessed by FFA
Time frame: Week 34 and Week 50
Annualized mean number of rescue treatments
Time frame: Week 34, Week 50 and Year 5
Change from baseline in the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) score
NEI VFQ-25 composite score ranges from 0 to 100. Higher scores indicate better vision-related functioning and quality of life. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.
Time frame: Week 34 and Week 50
Frequencies and severities of all safety events
Time frame: Week 34 and Year 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University People's Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Second Hospital of Jilin University
Jilin City, Changchun, China
NOT_YET_RECRUITINGSouthwest Hospital, Army Medical University(Southwest Hospital)
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGShantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China
NOT_YET_RECRUITINGZhejiang Provincial People's Hospital
Zhejiang, Hangzhou, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGGeneral Hospital of Central Theater Command, Chinese People's Liberation Army
Wuhan, Hubei, China
NOT_YET_RECRUITINGJiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
NOT_YET_RECRUITING...and 6 more locations