TAB014 Compared to Lucentis® in Patients With Neovascular Age-related Macular Degeneration (nAMD)

March 2, 2023 updated by: TOT Biopharm Co., Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

488

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • YouXin Chen, PhD
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Beijing Aier Intech Eye Hospital
        • Contact:
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital, Cmu
        • Contact:
    • Changchun
      • Jilin, Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Fujian
      • Amoy, Fujian, China, 361004
        • Not yet recruiting
        • Xiamen Eye Center of Xiamen University
        • Contact:
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical
        • Contact:
      • Guangzhou, Guangdong, China, 510623
        • Not yet recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
      • Shantou, Guangdong, China, 515041
        • Not yet recruiting
        • Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
        • Contact:
          • Junfeng Zhu
          • Phone Number: 86-0754-88393578
          • Email: gcp@jsiec.org
      • Shenzhen, Guangdong, China, 518031
        • Recruiting
        • Shenzhen Aier Eye Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 061017
        • Recruiting
        • Cangzhou Central Hospital
        • Contact:
      • Xingtai, Hebei, China, 054001
        • Recruiting
        • Hebei Eye Hospital
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150001
        • Recruiting
        • The First Affiliated Hospital Of Harbin Medical University
        • Contact:
    • Henan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Kaifeng Central Hopital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Eye Hospital& Henan Eye Institute
        • Contact:
      • Zhengzhou, Henan, China, 450015
        • Recruiting
        • Zhengzhou Second Hospital
        • Contact:
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Recruiting
        • Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430081
        • Recruiting
        • Wuhan Puren Hospital
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital® Tongji Medical Collehe of Hust
        • Contact:
      • Wuhan, Hubei, China, 430070
        • Recruiting
        • Central theater General Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410015
        • Recruiting
        • Aier Eye Hospital(Changsha)
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010030
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Recruiting
        • Wuxi No.2 People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Affiliated Eye Hospital of Nanchang University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116091
        • Recruiting
        • Dalian No.3 People'S Hospital
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The Fourth People's Hospital of Shenyang
        • Contact:
      • Shenyang, Liaoning, China, 110034
        • Recruiting
        • Shenyang He Eye Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250021
        • Not yet recruiting
        • Jinan 2Nd People'S Hospital
        • Contact:
      • Weifang, Shandong, China, 261041
        • Recruiting
        • Weifang Eye Hospital Co., Ltd.
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200041
        • Not yet recruiting
        • Shanghai Eye Disease Prevention and Treatment Center
        • Contact:
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital(Tenth People's Hospital of Tongji Unversity)
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Recruiting
        • Changzhi People's Hospital
        • Contact:
      • Jinzhong, Shanxi, China, 030699
        • Recruiting
        • The First People's Hospital of Jinzhong(Jinzhong Hospital Affiliated to Shanxi Medical University)
        • Contact:
      • Taiyuan, Shanxi, China, 030002
        • Recruiting
        • Shanxi Eye Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710002
        • Recruiting
        • Xi'an No.1 Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710004
        • Recruiting
        • Xi'an Fourth Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Chengdu Aier Eye Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610084
        • Recruiting
        • Ineye Hospital of Chengdu University of TCM
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • TianJin eye hospital
        • Contact:
      • Tianjin, Tianjin, China, 300384
        • Not yet recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
        • Contact:
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • Eye Hospital, WMU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 the screening period ;

  4. Confirmed by independent central reading center:

    1. Total lesion area ≤ 12 optic disc areas in the study eye,
    2. Fibrotic, scarring or atrophy < 50% of total lesion area, without involving the fovea,
    3. Retinal hemorrhage involving the foveal or intraretinal hemorrhage < 4 optic disc area,
  5. Able to understand and personally sign informed consent form.

Exclusion Criteria:

  1. Ophthalmic Treatment history:

    1. Intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab, aflibercept or conbercept, etc.) in any eye within 90 days prior to randomization;
    2. 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;
    3. 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;
    4. Intravitreal therapy in the study eye (e.g. steroids or device implants) within 180 days before randomization;
    5. PDT (Photodynamic Therapy) in the non-study eye within 30 days before screening;
    6. Central serous chorioretinopathy (CSC) in the study eye;
  2. The non-study eye confirmed to have a BCVA on ETDRS chart of < 18 letters during screening;
  3. 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;
  4. 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;
  5. 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
  6. 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;
  7. Active intraocular, extraocular, or periocular inflammation or infection in either eye at randomization;
  8. History of idiopathic or autoimmune-associated uveitis in either;
  9. Active Hepatitis B, C or syphillis; HIV antibody positive; presence of any immune deficient, and/or immune suppressed illnesses;
  10. Poorly controlled hypertension after receiving the best possible therapy;
  11. Diabetic patients with HbA1c >10%;
  12. 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;
  13. 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;
  14. Anti-VEGF therapy within 90 days prior to randomization; subjects are allowed to take any dietary supplements, vitamins or minerals;
  15. Continuous systemic use ≥ 30days of corticosteroids within 90 days before randomization, or systemic use of corticosteroids within 5 days before randomization;
  16. 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);
  17. 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;
  18. 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;
  19. Other conditions that are considered not acceptable to be enrolled in the study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAB014
intravitreal injection at 1.25mg once every 4 week
Drug: TAB014 Monoclonal Antibody Injection
intravitreal injection at 1.25mg once every 4 weeks
Other Names:
  • TAB014
Active Comparator: Ranibizumb
intravitreal injection at 0.5mg once every 4 week
Drug: Ranibizumab Injection [Lucentis]
intravitreal injection at 0.5mg once every 4 weeks
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups.
Time Frame: At week 52
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
At week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the change in BCVA of the study eye
Time Frame: At week 12, 24 and 36
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
Time Frame: At week 12, 24 and 52
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
Time Frame: At week 12, 24 and 52
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
Time Frame: At week 12, 24, 36 and 52
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
Time Frame: At week 12, 24 and 52
CNV as assessed by independent central reading center
At week 12, 24 and 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation
Time Frame: Baseline and every month up to week 52
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
Immunogenicity Evaluation
Time Frame: At week 12, 24 and 52
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TOT Biopharm Co., Ltd.

Collaborators

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Investigators

  • Principal Investigator: YouXin Chen, PHD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOT-CR-TAB014-III-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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