TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration

Last updated: January 3, 2025
Sponsor: TOT Biopharm Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Geographic Atrophy

Macular Degeneration

Treatment

TAB014 Monoclonal Antibody Injection

Ranibizumab Injection [Lucentis]

Clinical Study ID

NCT05461339
TOT-CR-TAB014-III-01
  • Ages 50-90
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be > 50 years old, male or female;

  2. Confirmed active subfoveal or juxtafoveal choroidal neovascularization (CNV)secondary to nAMD in the study eye;

  3. BCVA letter score between 15 and 73 (inclusive) by the ETDRS chart during thescreening period ;

  4. Confirmed by independent central reading center:

  5. Total lesion area ≤ 12 optic disc areas in the study eye,

  6. Fibrotic, scarring or atrophy < 50% of total lesion area, without involving thefovea,

  7. Retinal hemorrhage involving the foveal or intraretinal hemorrhage < 4 opticdisc area,

  8. Able to understand and personally sign informed consent form.

Exclusion

Exclusion Criteria:

  1. Ophthalmic Treatment history:

  2. Intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab,aflibercept or conbercept, etc.) in any eye within 90 days prior torandomization;

  3. 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;

  4. Prior intra-ocular (including cataract) surgery in the study eye within 90 daysbefore randomization, or surgery to the exterior eye within 28 days beforerandomization;

  5. Intravitreal therapy in the study eye (e.g. steroids or device implants) within 180 days before randomization;

  6. PDT (Photodynamic Therapy) in the non-study eye within 30 days beforescreening;

  7. Central serous chorioretinopathy (CSC) in the study eye;

  8. The non-study eye confirmed to have a BCVA on ETDRS chart of < 18 letters duringscreening;

  9. 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;

  10. 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;

  11. 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

  12. 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;

  13. Active intraocular, extraocular, or periocular inflammation or infection in eithereye at randomization;

  14. History of idiopathic or autoimmune-associated uveitis in either;

  15. Active Hepatitis B, C or syphillis; HIV antibody positive; presence of any immunedeficient, and/or immune suppressed illnesses;

  16. Poorly controlled hypertension after receiving the best possible therapy;

  17. Diabetic patients with HbA1c >10%;

  18. 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;

  19. 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;

  20. Anti-VEGF therapy within 90 days prior to randomization; subjects are allowed totake any dietary supplements, vitamins or minerals;

  21. Continuous systemic use ≥ 30days of corticosteroids within 90 days beforerandomization, or systemic use of corticosteroids within 5 days beforerandomization;

  22. 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);

  23. 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;

  24. 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;

  25. Other conditions that are considered not acceptable to be enrolled in the study bythe investigator.

Study Design

Total Participants: 488
Treatment Group(s): 2
Primary Treatment: TAB014 Monoclonal Antibody Injection
Phase: 3
Study Start date:
June 28, 2022
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Beijing Aier Intech Eye Hospital

    Beijing, Beijing 100021
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Beijing Tongren Hospital, Cmu

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University People'S Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • The First Hospital of Jilin University

    Jilin, Changchun 130021
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • Xiamen Eye Center of Xiamen University

    Amoy, Fujian 361004
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical

    Guangzhou, Guangdong 510260
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou, Guangdong 510623
    China

    Site Not Available

  • Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Shenzhen Aier Eye Hospital

    Shenzhen, Guangdong 518031
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550004
    China

    Site Not Available

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061017
    China

    Site Not Available

  • Hebei Eye Hospital

    Xingtai, Hebei 054001
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang 150001
    China

    Site Not Available

  • Kaifeng Central Hopital

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Henan Eye Hospital& Henan Eye Institute

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Zhengzhou Second Hospital

    Zhengzhou, Henan 450015
    China

    Site Not Available

  • Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Central theater General Hospital

    Wuhan, Hubei 430070
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Tongji Hospital® Tongji Medical Collehe of Hust

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Wuhan Puren Hospital

    Wuhan, Hubei 430081
    China

    Site Not Available

  • Aier Eye Hospital(Changsha)

    Changsha, Hunan 410015
    China

    Site Not Available

  • Hunan Provincial People's Hospital

    Changsha, Hunan 410005
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010030
    China

    Site Not Available

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu 214002
    China

    Site Not Available

  • Affiliated Eye Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330008
    China

    Site Not Available

  • Dalian No.3 People'S Hospital

    Dalian, Liaoning 116091
    China

    Site Not Available

  • Shenyang He Eye Hospital

    Shenyang, Liaoning 110034
    China

    Site Not Available

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Jinan 2Nd People'S Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Weifang Eye Hospital Co., Ltd.

    Weifang, Shandong 261041
    China

    Site Not Available

  • Shanghai Eye Disease Prevention and Treatment Center

    Shanghai, Shanghai 200041
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • Shanghai Tenth People's Hospital(Tenth People's Hospital of Tongji Unversity)

    Shanghai, Shanghai 200072
    China

    Site Not Available

  • Changzhi People'S Hospital

    Changzhi, Shanxi 046000
    China

    Site Not Available

  • The First People's Hospital of Jinzhong(Jinzhong Hospital Affiliated to Shanxi Medical University)

    Jinzhong, Shanxi 030699
    China

    Site Not Available

  • Shanxi Eye Hospital

    Taiyuan, Shanxi 030002
    China

    Site Not Available

  • Xi'An Fourth Hospital

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • Xi'an No.1 Hospital

    Xi'an, Shanxi 710002
    China

    Site Not Available

  • Chengdu Aier Eye Hospital

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Ineye Hospital of Chengdu University of TCM

    Chengdu, Sichuan 610084
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Eye Hospital

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin 300384
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Provincial People'S Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Eye Hospital, WMU

    Wenzhou, Zhejiang 325027
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Site Not Available

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