this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.
This is a Phase 3, multicenter, randomized double masked active controlled study to compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD. The study will be conducted in approximately 60 sites in China. Either HLX04-O (1.25 mg) IVT or ranibizumab (0.5 mg) IVT will be administered at a 4-week interval for 1 year (12 cycles).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
407
0.05mL solution at a 4-week interval for intravitreal injection
0.05mL solution at a 4-week interval for intravitreal injection
Mean change of letters from baseline in best-corrected visual acuity (BCVA) at Week 48.
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: from baseline to week 48
Mean change of letters from baseline in the BCVA over time
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
Proportion of patients gaining at least 15/10/5 letters in the BCVA at Week 12, 24, 36 and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
Mean change from baseline in the total area of CNV and the total area of fluorescein leakage on fluorescein angiography (FA) at Week 12, 24 and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
Mean change from baseline in central retina thickness (CRT) on optical coherence tomography (OCT) at Week 12, 24, 36 and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
Change from baseline in National Eye Institute Visual Functioning Questionnaire - 25 scale score at Week 12, 24, and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
Percentage and severity of ocular AEs (IVT procedure related and Investigation Medication related), non-ocular AEs; laboratory abnormalities; vital sign, physical examination abnormalities, etc.
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Third Military Medical University (Southwest Hospital)
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital )
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
...and 31 more locations
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
Incidence of ADAs and NAbs against HLX04-O following IVT administration
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48
HLX04-O serum concentrations before Dose 1, Dose 2, Dose 6, Dose 9 and Dose 12 and the last visit as data permit.
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: From baseline to week 48