Phase
Condition
Geographic Atrophy
Macular Degeneration
Treatment
TAB014 Monoclonal Antibody Injection
Ranibizumab Injection [Lucentis]
Clinical Study ID
Ages 50-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thescreening 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 thefovea,
Retinal hemorrhage involving the foveal or intraretinal hemorrhage < 4 opticdisc area,
Able to understand and personally sign informed consent form.
Exclusion
Exclusion Criteria:
Ophthalmic Treatment history:
Intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab,aflibercept or conbercept, etc.) in any eye within 90 days prior torandomization;
Prior vitrectomy, panretinal photocoagulation, laser treatment of the fovealarea or ocular treatment/surgery for nAMD in the study eye; or history ofcorneal 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 daysbefore randomization, or surgery to the exterior eye within 28 days beforerandomization;
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 beforescreening;
Central serous chorioretinopathy (CSC) in the study eye;
The non-study eye confirmed to have a BCVA on ETDRS chart of < 18 letters duringscreening;
Myopia more than -8.0 diopters of refractive error in study eye; For patients whohave undergone refractive surgery or cataract surgery, refraction must not have beengreater 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 capsulotomyreceived 30 days before randomization or expect to receive during the study periodin study eye;
Ocular disorders in the study eye as determined by the investigator at the presenttime: (a) effects on the central vision, or (b) increasing safety risk for thesubject, or (c) affecting efficacy, safety evaluation or sampling, or (d) havingocular 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 orendangering the central visual field;
Active intraocular, extraocular, or periocular inflammation or infection in eithereye at randomization;
History of idiopathic or autoimmune-associated uveitis in either;
Active Hepatitis B, C or syphillis; HIV antibody positive; presence of any immunedeficient, 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;dysfunctionof blood coagulation; cardiovascular events within 180 days before randomization anddetermined by investigator can affect subject safety evaluation or increase subjectrisk;
Prior significant allergic reactions to biological products, or known allergicreactions to bevacizumab, ranibizumab, or study related medication (includingfluorescein or indocyanin green), pupillary dilating agents, anaesthetic agents, oranti-infective agents;
Anti-VEGF therapy within 90 days prior to randomization; subjects are allowed totake any dietary supplements, vitamins or minerals;
Continuous systemic use ≥ 30days of corticosteroids within 90 days beforerandomization, or systemic use of corticosteroids within 5 days beforerandomization;
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 thanvitamins and minerals) within 90 days prior to randomization; And the use of anyother experimental drugs or experimental interventions other than those of thisstudy (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 6months of study termination (including male subjects). Premenopausal woman testingpositive for pregnancy during screening or is reluctant to use reliablecontraceptive methods during the study periods;
Other conditions that are considered not acceptable to be enrolled in the study bythe investigator.
Study Design
Study Description
Connect with a study center
The Second Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaSite Not Available
Beijing Aier Intech Eye Hospital
Beijing, Beijing 100021
ChinaSite Not Available
Beijing Hospital
Beijing, Beijing 100730
ChinaSite Not Available
Beijing Tongren Hospital, Cmu
Beijing, Beijing 100730
ChinaSite Not Available
Peking University People'S Hospital
Beijing, Beijing 100044
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing 100191
ChinaSite Not Available
The First Hospital of Jilin University
Jilin, Changchun 130021
ChinaSite Not Available
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 400016
ChinaSite Not Available
Xiamen Eye Center of Xiamen University
Amoy, Fujian 361004
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350005
ChinaSite Not Available
Guangzhou First People's Hospital
Guangzhou, Guangdong 510180
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
The Second Affiliated Hospital of Guangzhou Medical
Guangzhou, Guangdong 510260
ChinaSite Not Available
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong 510623
ChinaSite Not Available
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong 515041
ChinaSite Not Available
Shenzhen Aier Eye Hospital
Shenzhen, Guangdong 518031
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou 550004
ChinaSite Not Available
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou 563000
ChinaSite Not Available
Cangzhou Central Hospital
Cangzhou, Hebei 061017
ChinaSite Not Available
Hebei Eye Hospital
Xingtai, Hebei 054001
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Ha'erbin, Heilongjiang 150001
ChinaSite Not Available
Kaifeng Central Hopital
Kaifeng, Henan 475000
ChinaSite Not Available
Henan Eye Hospital& Henan Eye Institute
Zhengzhou, Henan 450008
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaSite Not Available
Zhengzhou Second Hospital
Zhengzhou, Henan 450015
ChinaSite Not Available
Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)
Shiyan, Hubei 442000
ChinaSite Not Available
Central theater General Hospital
Wuhan, Hubei 430070
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, Hubei 430060
ChinaSite Not Available
Tongji Hospital® Tongji Medical Collehe of Hust
Wuhan, Hubei 430030
ChinaSite Not Available
Wuhan Puren Hospital
Wuhan, Hubei 430081
ChinaSite Not Available
Aier Eye Hospital(Changsha)
Changsha, Hunan 410015
ChinaSite Not Available
Hunan Provincial People's Hospital
Changsha, Hunan 410005
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan 410008
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia 010030
ChinaSite Not Available
Wuxi No.2 People's Hospital
Wuxi, Jiangsu 214002
ChinaSite Not Available
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330008
ChinaSite Not Available
Dalian No.3 People'S Hospital
Dalian, Liaoning 116091
ChinaSite Not Available
Shenyang He Eye Hospital
Shenyang, Liaoning 110034
ChinaSite Not Available
The Fourth People's Hospital of Shenyang
Shenyang, Liaoning 110000
ChinaSite Not Available
Jinan 2Nd People'S Hospital
Jinan, Shandong 250021
ChinaSite Not Available
Weifang Eye Hospital Co., Ltd.
Weifang, Shandong 261041
ChinaSite Not Available
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai 200041
ChinaSite Not Available
Shanghai General Hospital
Shanghai, Shanghai 200080
ChinaSite Not Available
Shanghai Tenth People's Hospital(Tenth People's Hospital of Tongji Unversity)
Shanghai, Shanghai 200072
ChinaSite Not Available
Changzhi People'S Hospital
Changzhi, Shanxi 046000
ChinaSite Not Available
The First People's Hospital of Jinzhong(Jinzhong Hospital Affiliated to Shanxi Medical University)
Jinzhong, Shanxi 030699
ChinaSite Not Available
Shanxi Eye Hospital
Taiyuan, Shanxi 030002
ChinaSite Not Available
Xi'An Fourth Hospital
Xi'an, Shanxi 710004
ChinaSite Not Available
Xi'an No.1 Hospital
Xi'an, Shanxi 710002
ChinaSite Not Available
Chengdu Aier Eye Hospital
Chengdu, Sichuan 610041
ChinaSite Not Available
Ineye Hospital of Chengdu University of TCM
Chengdu, Sichuan 610084
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
Tianjin Eye Hospital
Tianjin, Tianjin 300020
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin, Tianjin 300384
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang 310003
ChinaSite Not Available
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang 310014
ChinaSite Not Available
Eye Hospital, WMU
Wenzhou, Zhejiang 325027
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, 100730
ChinaSite Not Available
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