TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration
nAMD
A Phase III, Randomized, Multicenter, Doubled-blind Clinical Trial Comparing the Efficacy and Safety of TAB014 and Lucentis in Neovascular Age-related Macular Degeneration (nAMD) Patients
1 other identifier
interventional
488
1 country
56
Brief Summary
This study is a randomized, multi-center, double blind, Lucentis controlled non-inferiority study in neovascular age-related macular degeneration patients. The objective of this study is to compare the efficacy and safety of TAB014 and ranibizumab (Lucentis).
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 Jun 2022
Typical duration for phase_3
56 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
Study Start
First participant enrolled
June 28, 2022
CompletedFirst Submitted
Initial submission to the registry
July 12, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJanuary 7, 2025
January 1, 2025
2.2 years
July 12, 2022
January 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups.
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
At week 52
Secondary Outcomes (5)
Evaluate the change in BCVA of the study eye
At week 12, 24 and 36
Evaluate the proportion of subjects with an increase in BCVA of >5, >10, and >15 in the study eye
At week 12, 24 and 52
Evaluate the proportion of subjects with a BCVA loss of <5, <10, < 15 letters in the study eye
At week 12, 24 and 52
Change in central subfield thickness（CST) in the study eye
At week 12, 24, 36 and 52
Change in Choroidal Neovascularization (CNV) area of study eye
At week 12, 24 and 52
Other Outcomes (2)
Safety Evaluation
Baseline and every month up to week 52
Immunogenicity Evaluation
At week 12, 24 and 52
Study Arms (2)
TAB014
EXPERIMENTALintravitreal injection at 1.25mg once every 4 week
Ranibizumb
ACTIVE COMPARATORintravitreal injection at 0.5mg once every 4 week
Interventions
intravitreal injection at 1.25mg once every 4 weeks
intravitreal injection at 0.5mg once every 4 weeks
Eligibility Criteria
You may qualify if:
- Patients must be \> 50 years old, male or female;
- Confirmed active subfoveal or juxtafoveal choroidal neovascularization (CNV) secondary to nAMD in the study eye;
- BCVA letter score between 15 and 73 (inclusive) by the ETDRS chart during the screening period ;
- Confirmed by independent central reading center:
- Total lesion area ≤ 12 optic disc areas in the study eye,
- Fibrotic, scarring or atrophy \< 50% of total lesion area, without involving the fovea,
- Retinal hemorrhage involving the foveal or intraretinal hemorrhage \< 4 optic disc area,
- Able to understand and personally sign informed consent form.
You may not qualify if:
- Ophthalmic Treatment history:
- Intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab, aflibercept or conbercept, etc.) in any eye within 90 days prior to randomization;
- Prior vitrectomy, panretinal photocoagulation, laser treatment of the foveal area or ocular treatment/surgery for nAMD in the study eye; or history of corneal transplantation or corneal dystrophy, treatment with verteporfin, external radiation therapy of the head or the eye, transpupillary hyperthermia;
- Prior intra-ocular (including cataract) surgery in the study eye within 90 days before randomization, or surgery to the exterior eye within 28 days before randomization;
- Intravitreal therapy in the study eye (e.g. steroids or device implants) within 180 days before randomization;
- PDT (Photodynamic Therapy) in the non-study eye within 30 days before screening;
- Central serous chorioretinopathy (CSC) in the study eye;
- The non-study eye confirmed to have a BCVA on ETDRS chart of \< 18 letters during screening;
- Myopia more than -8.0 diopters of refractive error in study eye; For patients who have undergone refractive surgery or cataract surgery, refraction must not have been greater than -8.0 diopters prior to surgery;
- Absence of the crystalline lens (unless there has been artificial lens replacement), or presence of posterior lens capsule rupture, or YAG laser posterior capsulotomy received 30 days before randomization or expect to receive during the study period in study eye;
- Ocular disorders in the study eye as determined by the investigator at the present time: (a) effects on the central vision, or (b) increasing safety risk for the subject, or (c) affecting efficacy, safety evaluation or sampling, or (d) having ocular diseases requiring surgical or medical intervention
- In the study eye, (a) presence of uncontrolled glaucoma at randomization, or (b) prior glaucoma surgery, or (c) advanced glaucoma or optic neuropathy, affecting or endangering the central visual field;
- Active intraocular, extraocular, or periocular inflammation or infection in either eye at randomization;
- History of idiopathic or autoimmune-associated uveitis in either;
- Active Hepatitis B, C or syphillis; HIV antibody positive; presence of any immune deficient, and/or immune suppressed illnesses;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Aier Intech Eye Hospital
Beijing, Beijing Municipality, 100021, China
Peking University People'S Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, 100730, China
The First Hospital of Jilin University
Jilin, Changchun, 130021, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The Second Affiliated Hospital of Guangzhou Medical
Guangzhou, Guangdong, 510260, China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510623, China
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, 515041, China
Shenzhen Aier Eye Hospital
Shenzhen, Guangdong, 518031, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061017, China
Hebei Eye Hospital
Xingtai, Hebei, 054001, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Kaifeng Central Hopital
Kaifeng, Henan, 475000, China
Henan Eye Hospital& Henan Eye Institute
Zhengzhou, Henan, 450008, China
Zhengzhou Second Hospital
Zhengzhou, Henan, 450015, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)
Shiyan, Hubei, 442000, China
Tongji Hospital® Tongji Medical Collehe of Hust
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Central theater General Hospital
Wuhan, Hubei, 430070, China
Wuhan Puren Hospital
Wuhan, Hubei, 430081, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Aier Eye Hospital(Changsha)
Changsha, Hunan, 410015, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002, China
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
Dalian No.3 People'S Hospital
Dalian, Liaoning, 116091, China
The Fourth People's Hospital of Shenyang
Shenyang, Liaoning, 110000, China
Shenyang He Eye Hospital
Shenyang, Liaoning, 110034, China
Weifang Eye Hospital Co., Ltd.
Weifang, Shandong, 261041, China
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200041, China
Shanghai Tenth People's Hospital(Tenth People's Hospital of Tongji Unversity)
Shanghai, Shanghai Municipality, 200072, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Changzhi People'S Hospital
Changzhi, Shanxi, 046000, China
The First People's Hospital of Jinzhong(Jinzhong Hospital Affiliated to Shanxi Medical University)
Jinzhong, Shanxi, 030699, China
Shanxi Eye Hospital
Taiyuan, Shanxi, 030002, China
Xi'an No.1 Hospital
Xi’an, Shanxi, 710002, China
Xi'An Fourth Hospital
Xi’an, Shanxi, 710004, China
Chengdu Aier Eye Hospital
Chengdu, Sichuan, 610041, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Ineye Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610084, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384, China
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, 310014, China
Eye Hospital, WMU
Wenzhou, Zhejiang, 325027, China
Peking Union Medical College Hospital
Beijing, 100730, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youxin Chen, PhD
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects, investigators responsible for patient care, vision examiner (including BCVA assessors), research nurses, independent central reading center staff, and the sponsor are blinded. Unmasked pharmacist, unmasked nurse, unmasked treatment administration physician and unmasked research associates will take part in this study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2022
First Posted
July 18, 2022
Study Start
June 28, 2022
Primary Completion
September 20, 2024
Study Completion
February 1, 2025
Last Updated
January 7, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share