TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Drug: TAB014 Monoclonal Antibody Injection
- Registration Number
- NCT05461339
- Lead Sponsor
- TOT Biopharm Co., Ltd.
- 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).
- Detailed Description
Primary Objectives:
To evaluate the efficacy of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients
Secondary Objectives:
1. To evaluate the safety of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients.
2. To evaluate the immunogenicity of TAB014 in neovascular age-related macular degeneration patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 488
-
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.
-
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;
-
Poorly controlled hypertension after receiving the best possible therapy;
-
Diabetic patients with HbA1c >10%;
-
Any unmanageable clinical illness; Severe liver and kidney abnormalities；dysfunction of blood coagulation; cardiovascular events within 180 days before randomization and determined by investigator can affect subject safety evaluation or increase subject risk;
-
Prior significant allergic reactions to biological products, or known allergic reactions to bevacizumab, ranibizumab, or study related medication (including fluorescein or indocyanin green), pupillary dilating agents, anaesthetic agents, or anti-infective agents;
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Anti-VEGF therapy within 90 days prior to randomization; subjects are allowed to take any dietary supplements, vitamins or minerals;
-
Continuous systemic use ≥ 30days of corticosteroids within 90 days before randomization, or systemic use of corticosteroids within 5 days before randomization;
-
Necessity to continue use of prohibited agents (drugs known to be toxic to the lens, retina, or optic nerve, including deoxyamine, chloroquine/hydroxychloroquine (braquinib), tamoxifen, phenothiazines, and ethambutol);
-
Participation in a study trial involving any drug or device therapy (other than vitamins and minerals) within 90 days prior to randomization; And the use of any other experimental drugs or experimental interventions other than those of this study (e.g. isostoluent blood thinning, intravitreal tissue plasminogen activators) is prohibited during the study period;
-
Pregnant or lactating women, or those with plans for pregnancy during or within 6 months of study termination (including male subjects). Premenopausal woman testing positive for pregnancy during screening or is reluctant to use reliable contraceptive methods during the study periods;
-
Other conditions that are considered not acceptable to be enrolled in the study by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAB014 TAB014 Monoclonal Antibody Injection intravitreal injection at 1.25mg once every 4 week Ranibizumb Ranibizumab Injection [Lucentis] intravitreal injection at 0.5mg once every 4 week
- Primary Outcome Measures
Name Time Method Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups. At week 52 Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
- Secondary Outcome Measures
Name Time Method Evaluate the change in BCVA of the study eye At week 12, 24 and 36 Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
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 Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
Evaluate the proportion of subjects with a BCVA loss of <5, <10, < 15 letters in the study eye At week 12, 24 and 52 Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
Change in central subfield thickness（CST) in the study eye At week 12, 24, 36 and 52 CST measured by SD-OCT as assessed by independent central reading center
Change in Choroidal Neovascularization (CNV) area of study eye At week 12, 24 and 52 CNV as assessed by independent central reading center
Trial Locations
- Locations (56)
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Aier Intech Eye Hospital
🇨🇳Beijing, Beijing, China
Peking University People'S Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Cmu
🇨🇳Beijing, Beijing, China
The First Hospital of Jilin University
🇨🇳Jilin, Changchun, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical
🇨🇳Guangzhou, Guangdong, China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
🇨🇳Shantou, Guangdong, China
Shenzhen Aier Eye Hospital
🇨🇳Shenzhen, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Hebei Eye Hospital
🇨🇳Xingtai, Hebei, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
Kaifeng Central Hopital
🇨🇳Kaifeng, Henan, China
Henan Eye Hospital& Henan Eye Institute
🇨🇳Zhengzhou, Henan, China
Zhengzhou Second Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)
🇨🇳Shiyan, Hubei, China
Tongji Hospital® Tongji Medical Collehe of Hust
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Central theater General Hospital
🇨🇳Wuhan, Hubei, China
Wuhan Puren Hospital
🇨🇳Wuhan, Hubei, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Aier Eye Hospital(Changsha)
🇨🇳Changsha, Hunan, China
Wuxi No.2 People's Hospital
🇨🇳Wuxi, Jiangsu, China
Affiliated Eye Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Dalian No.3 People'S Hospital
🇨🇳Dalian, Liaoning, China
The Fourth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
Shenyang He Eye Hospital
🇨🇳Shenyang, Liaoning, China
Weifang Eye Hospital Co., Ltd.
🇨🇳Weifang, Shandong, China
Shanghai Eye Disease Prevention and Treatment Center
🇨🇳Shanghai, Shanghai, China
Shanghai Tenth People's Hospital(Tenth People's Hospital of Tongji Unversity)
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Changzhi People'S Hospital
🇨🇳Changzhi, Shanxi, China
The First People's Hospital of Jinzhong(Jinzhong Hospital Affiliated to Shanxi Medical University)
🇨🇳Jinzhong, Shanxi, China
Shanxi Eye Hospital
🇨🇳Taiyuan, Shanxi, China
Xi'an No.1 Hospital
🇨🇳Xi'an, Shanxi, China
Xi'An Fourth Hospital
🇨🇳Xi'an, Shanxi, China
Chengdu Aier Eye Hospital
🇨🇳Chengdu, Sichuan, China
Ineye Hospital of Chengdu University of TCM
🇨🇳Chengdu, Sichuan, China
Tianjin Eye Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People'S Hospital
🇨🇳Hangzhou, Zhejiang, China
Eye Hospital, WMU
🇨🇳Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, China