Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD
A Phase 3 Randomized Double-masked Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection with Ranibizumab in Subjects with Wet Age Related Macular Degeneration (wAMD)
1 other identifier
interventional
407
1 country
41
Brief Summary
this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2021
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2024
CompletedMarch 24, 2025
March 1, 2025
2.5 years
July 8, 2021
March 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
from baseline to week 48
Secondary Outcomes (8)
Mean change of letters from baseline in the BCVA over time
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
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
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
From baseline to week 48
Change from baseline in National Eye Institute Visual Functioning Questionnaire - 25 scale score at Week 12, 24, and 48
From baseline to week 48
- +3 more secondary outcomes
Study Arms (2)
HLX04-O
EXPERIMENTALBiologic recombinant anti-VEGF humanized monoclonal antibody
Ranibizumab
ACTIVE COMPARATORBiologic anti-VEGF recombinant humanized monoclonal antibody fragment
Interventions
0.05mL solution at a 4-week interval for intravitreal injection
Eligibility Criteria
You may qualify if:
- Capable to understand and sign the informed consent form (ICF) which includes compliance with the ICF and this protocol. In the Investigator's judgment, willing and able to complete all visits and assessments adhering to the prohibitions and restrictions specified in this protocol.
- Women or men aged ≥50 years when signing the ICF.
- Newly diagnosed, untreated, active subfoveal or juxtafoveal CNV lesions secondary to AMD in the study eye. (Active CNV was defined as leakage on FA and subretinal or intraretinal fluid on OCT with confirmation of the reading center during screening).
- The total lesion area (including hemorrhage, scar and neovascularization) of the study eye ≤12 disc area (DA) with confirmation of the reading center before randomization a.
- The BCVA letters between 24 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
- Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.
- Participants' fellow (non-study) eye must have had a BCVA of 24 letters or better.
You may not qualify if:
- Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis or atrophy involving the fovea, or CNV due to other causes in the study eye (e.g., ocular histoplasmosis, trauma, or pathological myopia etc.) with confirmation of the reading center.
- The fellow (nonstudy) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD, trauma, pathological myopia, retina vein occlusion, diabetic macular edema, etc) in the next 3 months after randomization, in the investigator's judgment.
- Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.
- Vitreous hemorrhage in the study eye within 3 months prior to dose 1.
- Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥1 month prior to first dose) in the study eye.
- Corneal dystrophy or history of corneal transplantation, scleral softening or history of scleral softening, history of rhegmatogenous retinal detachment or macular hole (Stage II, III or IV) in the study eye.
- Uncontrolled glaucoma (defined as intraocular pressure \[IOP\] ≥25 mmHg despite treatment with antiglaucoma medication), and/or glaucoma filtering surgery (e.g., trabeculectomy, scleral nipping, non-penetrating trabeculectomy, etc.), or advanced glaucoma resulting in a cup/disc ratio \>0.8 in the study eye
- Equivalent spherical diopter of the study eye ≥-8D. For participants who had undergone refractive correction or cataract surgery, the equivalent spherical diopter of the study eye before surgery ≥-8D.
- Estimated by the Investigator, any concurrent intraocular condition except wAMD (e.g., diabetic retinopathy, dry AMD, retina vein occlusion, uveitis, angioid streaks, retinal detachment, epiretinal membrane, amblyopia, central serous chorioretinopathy, etc.) in the study eye that limited the potential to gain visual acuity upon treatment with the investigational product, or could have required medical or surgical intervention during the study to prevent or treat visual loss.
- Underwent intraocular surgery including verteporfin photodynamic therapy (PDT), transpupillary thermotherapy, macular translocation, vitrectomy, laser photocoagulation in macular area, other surgery in macular area or surgery to treat AMD.
- Previous extraocular or periocular surgery within 1 month or intraocular surgery (including cataract surgery, etc.) within 3 months prior to dose 1, or current unhealed wound, moderate or severe ulcer or history of fracture in the study eye.
- Subconjunctival or intraocular or systemic use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months) prior to dose 1 in the study eye.
- Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either eye or other ocular use of anti-VEGF drug within 3 months prior to dose 1.
- Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) prior to dose 1 and have used the test drug or received device treatment.
- Pregnancy or lactation.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
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
Jieyang People's Hospital
Jieyang, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanjing, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Luoyang Third People's Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
The Third Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Henan Eye Hospital
Zhengzhou, Henan, China
People's Hospital of Wuhan University (Hubei Provincial People's Hospital)
Wuhan, Hubei, China
Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan AIER Eye Hospital
Wuhan, Hubei, China
Wuhan Puren Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Hospital of Jilin University
Jilin, Jilin, China
Shenyang AIER Eye Hospital
Shenyang, Liaoning, China
Ningxia Hui Autonomous Region Peoples Hospital
Yinchuan, Ningxia, China
Shangdong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang Eye Hospital
Weifang, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200233, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China
Lishui Municioal Central Hospital
Lishui, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
August 12, 2021
Study Start
November 1, 2021
Primary Completion
May 7, 2024
Study Completion
May 7, 2024
Last Updated
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share