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| Name | Class |
|---|---|
| Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | INDUSTRY |
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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).
Primary Objectives:
To evaluate the efficacy of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAB014 | Experimental | intravitreal injection at 1.25mg once every 4 week |
|
| Ranibizumb | Active Comparator | intravitreal injection at 0.5mg once every 4 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAB014 Monoclonal Antibody Injection | Drug | intravitreal injection at 1.25mg once every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the change in BCVA of the study eye | Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Ocular and non-ocular adverse events, serious adverse events (SAEs), adverse events of special interest (AESI), etc. will be graded according to the Ophthalmic Adverse Event Grading Scale and NIA Guidelines for Adverse Events and Serious Adverse Events (September 2018 Edition). | Baseline and every month up to week 52 |
Inclusion Criteria:
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:
Able to understand and personally sign informed consent form.
Exclusion Criteria:
Ophthalmic Treatment history:
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;
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.
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| Name | Affiliation | Role |
|---|---|---|
| Youxin Chen, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China | ||
| Beijing Aier Intech Eye Hospital |
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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.
| Ranibizumab Injection [Lucentis] | Drug | intravitreal injection at 0.5mg once every 4 weeks |
|
|
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
| At week 12, 24 and 52 |
| Evaluate the proportion of subjects with a BCVA loss of <5, <10, < 15 letters in the study eye | Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart | At week 12, 24 and 52 |
| Change in central subfield thickness(CST) in the study eye | CST measured by SD-OCT as assessed by independent central reading center | At week 12, 24, 36 and 52 |
| Change in Choroidal Neovascularization (CNV) area of study eye | CNV as assessed by independent central reading center | At week 12, 24 and 52 |
| Immunogenicity Evaluation |
Detection of anti-drug antibody and/or neutralizing antibodies will be examined in approximately 80 patients with monocular nAMD and no prior anti-VEGF therapy in the non-study eye for detection of immunogenicity evaluation. |
| At week 12, 24 and 52 |
| 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 City | 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 20, 2025 | Oct 30, 2025 | 4 |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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