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Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD

Primary Purpose

Age Related Macular Degeneration

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HLX04-O,recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection
Lucentis
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Women or men aged ≥50 years when signing the ICF.
  3. 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).
  4. 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.
  5. The BCVA letters between 24 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  6. Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.
  7. Participants' fellow (non-study) eye must have had a BCVA of 24 letters or better.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Vitreous hemorrhage in the study eye within 3 months prior to dose 1.
  5. 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.
  6. 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.
  7. 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
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. Pregnancy or lactation.
  16. Infertile women fail to meet either of the following ones: 1) menopause (≥12 continuous months of amenorrhea with no identified cause other than menopause before screening); 2) surgically sterilized.

    Men or fertile women fail to meet both of the following ones: 1) women of childbearing potential must have a negative urine or serum pregnancy test result within 14 days prior to initiation of the study intervention, and should not breastfeed; If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of the study intervention. Effective contraceptive methods include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs.

  17. In the Investigator's judgment, there is evidence of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications (e.g. stroke or myocardial infarction within 6 months prior todose1, uncontrolled hypertension (systolic blood pressure≥160 mmHg, or diastolic blood pressure ≥100 mmHg), etc.).
  18. Uncontrolled diabetes (defined as HbA1c>10.0%).
  19. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN, and is clinically significant in the opinion of the Investigator.
  20. Abnormal coagulation function(prothrombin time ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN)
  21. Active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to dose 1.
  22. Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases.
  23. Current treatment for active systemic infection, or history of recurrent serious infections.
  24. Known active or suspected autoimmune diseases, requiring systemic immunosuppressive therapy.
  25. Positive for syphilis screening test or positive for human immunodeficiency virus (HIV) screening test.
  26. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
  27. In the Investigator's judgment, other conditions considered not amenable to this study.
  28. Participant who has been diagnosed to be COVID-19 or who has received COVID-19 vaccine within 1 month prior to dose 1.

Other protocol defined inclusion and exclusion criteria may apply.

Sites / Locations

  • The first affiliated hospital of bengbu medical collegeRecruiting
  • The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Beijing Tongren Hospital, Capital Medical UniversityRecruiting
  • Chinese PLA General HospitalRecruiting
  • Xuanwu Hospital, Capital Medical UniversityRecruiting
  • The First Affiliated Hospital of Third Military Medical University (Southwest Hospital)Recruiting
  • The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The Second Hospital of Lanzhou UniversityRecruiting
  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital )Recruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Jieyang People's HospitalRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • The People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting
  • Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • The First People's Hospital of ZunyiRecruiting
  • Cangzhou Central HospitalRecruiting
  • The First Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Luoyang Third People's HospitalRecruiting
  • The First Affiliated Hospital of Xinxiang Medical CollegeRecruiting
  • The Third Affiliated Hospital of Xinxiang Medical CollegeRecruiting
  • Henan Eye HospitalRecruiting
  • People's Hospital of Wuhan University (Hubei Provincial People's Hospital)Recruiting
  • Tongji hospital, Tongji medical college, Huazhong University of Science and TechnologyRecruiting
  • Wuhan AIER Eye HospitalRecruiting
  • Wuhan Puren HospitalRecruiting
  • Yichang Central People's HospitalRecruiting
  • Affiliated Eye Hospital of Nanchang UniversityRecruiting
  • the First Affiliated Hospital of Nanchang UniversityRecruiting
  • Pingxiang People's HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Shenyang AIER Eye HospitalRecruiting
  • Ningxia Hui Autonomous Region Peoples HospitalRecruiting
  • Shangdong Provincial HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Weifang Eye HospitalRecruiting
  • Shanghai General HospitalRecruiting
  • Shanghai Tenth People's HospitalRecruiting
  • Shanxi Eye HospitalRecruiting
  • Tianjin Eye HospitalRecruiting
  • Zhejiang provincial people's hospitalRecruiting
  • Lishui Municioal Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HLX04-O

Ranibizumab

Arm Description

Biologic recombinant anti-VEGF humanized monoclonal antibody

Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change of letters from baseline in the BCVA over time
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
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
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
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
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
Percentage and severity of ocular AEs (IVT procedure related and Investigation Medication related), non-ocular AEs; laboratory abnormalities; vital sign, physical examination abnormalities, etc.
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Incidence of ADAs and NAbs against HLX04-O following IVT administration
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
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

Full Information

First Posted
July 8, 2021
Last Updated
April 27, 2022
Sponsor
Shanghai Henlius Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT05003245
Brief Title
Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HLX04-O
Arm Type
Experimental
Arm Description
Biologic recombinant anti-VEGF humanized monoclonal antibody
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
Biologic anti-VEGF recombinant humanized monoclonal antibody fragment
Intervention Type
Drug
Intervention Name(s)
HLX04-O,recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection
Intervention Description
0.05mL solution at a 4-week interval for intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Lucentis
Intervention Description
0.05mL solution at a 4-week interval for intravitreal injection
Primary Outcome Measure Information:
Title
Mean change of letters from baseline in best-corrected visual acuity (BCVA) at Week 48.
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
from baseline to week 48
Secondary Outcome Measure Information:
Title
Mean change of letters from baseline in the BCVA over time
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
Proportion of patients gaining at least 15/10/5 letters in the BCVA at Week 12, 24, 36 and 48
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
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
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
Mean change from baseline in central retina thickness (CRT) on optical coherence tomography (OCT) at Week 12, 24, 36 and 48
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
Change from baseline in National Eye Institute Visual Functioning Questionnaire - 25 scale score at Week 12, 24, and 48
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
Percentage and severity of ocular AEs (IVT procedure related and Investigation Medication related), non-ocular AEs; laboratory abnormalities; vital sign, physical examination abnormalities, etc.
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
Incidence of ADAs and NAbs against HLX04-O following IVT administration
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48
Title
HLX04-O serum concentrations before Dose 1, Dose 2, Dose 6, Dose 9 and Dose 12 and the last visit as data permit.
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
From baseline to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Infertile women fail to meet either of the following ones: 1) menopause (≥12 continuous months of amenorrhea with no identified cause other than menopause before screening); 2) surgically sterilized. Men or fertile women fail to meet both of the following ones: 1) women of childbearing potential must have a negative urine or serum pregnancy test result within 14 days prior to initiation of the study intervention, and should not breastfeed; If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of the study intervention. Effective contraceptive methods include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. In the Investigator's judgment, there is evidence of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications (e.g. stroke or myocardial infarction within 6 months prior todose1, uncontrolled hypertension (systolic blood pressure≥160 mmHg, or diastolic blood pressure ≥100 mmHg), etc.). Uncontrolled diabetes (defined as HbA1c>10.0%). Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN, and is clinically significant in the opinion of the Investigator. Abnormal coagulation function(prothrombin time ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN) Active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to dose 1. Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases. Current treatment for active systemic infection, or history of recurrent serious infections. Known active or suspected autoimmune diseases, requiring systemic immunosuppressive therapy. Positive for syphilis screening test or positive for human immunodeficiency virus (HIV) screening test. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study. In the Investigator's judgment, other conditions considered not amenable to this study. Participant who has been diagnosed to be COVID-19 or who has received COVID-19 vaccine within 1 month prior to dose 1. Other protocol defined inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Jin, Bachelor
Phone
+86-15955160489
Email
qi_jin@henlius.com
Facility Information:
Facility Name
The first affiliated hospital of bengbu medical college
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wan
Phone
0552-3085746
Email
419117369@qq.com
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yu
Phone
0551-65997421
Email
officegcp@ayefy.com
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuyang Dai
Phone
010-5826848-8001/13811057723
Email
bjtrgcp@163.com
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beibei Liang
Phone
010-66939409
Email
113910635134@163.com
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanbo Lv
Phone
010-63131272
Email
xwgcpht@xwh.ccmu.edu.cn
Facility Name
The First Affiliated Hospital of Third Military Medical University (Southwest Hospital)
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mr Pan
Phone
023-68766775
Email
993725117@qq.com
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohong Long
Phone
023-62888290
Email
chongergcp@163.com
Facility Name
The Second Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Qiu
Phone
0931-8487117
Email
ldeygcp@163.com
Facility Name
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital )
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingcui Huang
Phone
020-38688462
Email
drugbase@163.com
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Li
Phone
020-62783374
Email
zjyygcp@163.com
Facility Name
Jieyang People's Hospital
City
Jieyang
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haowei Liu
Phone
0663-8660801
Email
project_jysrmyy@126.com
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanjing
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanwen Zhou
Phone
0771- 5356080
Email
gxzywjg@163.com
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Huang
Phone
0771-2186377
Email
hxm1009@126.com
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Liu
Phone
+86(851)86752817
Email
2668092677@qq.com
Facility Name
The First People's Hospital of Zunyi
City
Zunyi
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li
Phone
0851-23233831
Email
zsyygcp@126.com
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyang Sun
Phone
0317-2072825
Email
czzxyygcp@126.com
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Ren
Phone
0451-85552399
Email
renxiaohui2004@163.com
Facility Name
Luoyang Third People's Hospital
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Chen
Phone
0379-63963566
Email
lysygcp@163.com
Facility Name
The First Affiliated Hospital of Xinxiang Medical College
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Liang
Phone
0373-4404384
Email
yfygcp4384@163.com
Facility Name
The Third Affiliated Hospital of Xinxiang Medical College
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Wang
Phone
0373-3029575
Email
xysfygcp@163.com
Facility Name
Henan Eye Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijuan He
Phone
0371-67120925
Email
hehui0111@126.com
Facility Name
People's Hospital of Wuhan University (Hubei Provincial People's Hospital)
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiantian Duan
Phone
027-88237069
Email
3375565387@qq.com
Facility Name
Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Shu
Phone
027-83663940
Email
tongjigcp@163.com
Facility Name
Wuhan AIER Eye Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Chen
Phone
027-68893766
Email
whaiergcp@163.com
Facility Name
Wuhan Puren Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Lv
Phone
027-86360089
Email
Prjgb_gcp@126.com
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liling Hu
Phone
0717-6487063
Email
ycsgcp@163.com
Facility Name
Affiliated Eye Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Yuan
Phone
13803527527
Email
361188958@qq.com
Facility Name
the First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Wen
Phone
0791-88695051
Email
ncuyfygcp2018@163.com
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lv Xiao
Phone
0799-6881723
Email
pxsrmyygcp@163.com
Facility Name
The First Hospital of Jilin University
City
Jilin
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Wang
Phone
0431-88786014
Email
wangfei5780@126.com
Facility Name
Shenyang AIER Eye Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongshan Zhang
Phone
15004008229
Email
tszhang61@163.com
Facility Name
Ningxia Hui Autonomous Region Peoples Hospital
City
Yinchuan
State/Province
Ningxia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xnyuan Cao
Phone
0951-5920163
Facility Name
Shangdong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxuan Huang
Phone
0531-68776009
Email
shiyanjigouban@126.com
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Li
Phone
0532-82912263
Email
jidi1767@126.com
Facility Name
Weifang Eye Hospital
City
Weifang
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Jiang
Phone
18363691272
Email
wfykyyjgb@163.com
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Xu
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Teng
Phone
021-66301632
Email
sygcp2013@126.com
Facility Name
Shanxi Eye Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang
Phone
13753124052
Email
sxykywjg@163.com
Facility Name
Tianjin Eye Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang
Phone
15522516709
Email
tjsykyy@163.com
Facility Name
Zhejiang provincial people's hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang
Phone
0571-85893646
Email
zzsrmyygcp@163.c0m
Facility Name
Lishui Municioal Central Hospital
City
Lishui
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yayan Zhu
Phone
0578-2285718
Email
lsszxyygcp@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD

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