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Neovascular Age-related Macular DegenerationPhase 3nAMDNCT05461339

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

A Phase 3 study testing TAB014 Monoclonal Antibody Injection and Ranibizumab Injection [Lucentis] in people with Neovascular Age-related Macular Degeneration, run by BioDlink Biopharm Co., Ltd. at 56 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
TAB014 Monoclonal Antibody Injection and Ranibizumab Injection [Lucentis]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
56 sitesChina
Study dates
28 Jun 2022to Feb 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • 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.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

China56 sites

  • Beijing Aier Intech Eye Hospital

    Beijing, Beijing Municipality, 100021

  • Peking University People'S Hospital

    Beijing, Beijing Municipality, 100044

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Tongren Hospital, Cmu

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061017

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Aier Eye Hospital(Changsha)

    Changsha, Hunan, 410015

  • Changzhi People'S Hospital

    Changzhi, Shanxi, 046000

  • Chengdu Aier Eye Hospital

    Chengdu, Sichuan, 610041

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Ineye Hospital of Chengdu University of TCM

    Chengdu, Sichuan, 610084

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Dalian No.3 People'S Hospital

    Dalian, Liaoning, 116091

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guangzhou Medical

    Guangzhou, Guangdong, 510260

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou, Guangdong, 510623

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

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

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial People'S Hospital

    Hangzhou, Zhejiang, 310014

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The First Hospital of Jilin University

    Jilin City, Changchun, 130021

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

    Jinzhong, Shanxi, 030699

  • Kaifeng Central Hopital

    Kaifeng, Henan, 475000

  • Affiliated Eye Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008

  • Shanghai Eye Disease Prevention and Treatment Center

    Shanghai, Shanghai Municipality, 200041

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

    Shanghai, Shanghai Municipality, 200072

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

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

    Shantou, Guangdong, 515041

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning, 110000

  • Shenyang He Eye Hospital

    Shenyang, Liaoning, 110034

  • Shenzhen Aier Eye Hospital

    Shenzhen, Guangdong, 518031

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

    Shiyan, Hubei, 442000

  • Shanxi Eye Hospital

    Taiyuan, Shanxi, 030002

  • Tianjin Eye Hospital

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality, 300384

  • Weifang Eye Hospital Co., Ltd.

    Weifang, Shandong, 261041

  • Eye Hospital, WMU

    Wenzhou, Zhejiang, 325027

  • Tongji Hospital® Tongji Medical Collehe of Hust

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Central theater General Hospital

    Wuhan, Hubei, 430070

  • Wuhan Puren Hospital

    Wuhan, Hubei, 430081

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu, 214002

  • Xi'an No.1 Hospital

    Xi’an, Shanxi, 710002

  • Xi'An Fourth Hospital

    Xi’an, Shanxi, 710004

  • Hebei Eye Hospital

    Xingtai, Hebei, 054001

  • Henan Eye Hospital& Henan Eye Institute

    Zhengzhou, Henan, 450008

  • Zhengzhou Second Hospital

    Zhengzhou, Henan, 450015

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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).

Read the 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.
Being tested
TAB014 Monoclonal Antibody Injection, Ranibizumab Injection [Lucentis]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAB014 Monoclonal Antibody InjectionDrug

    Also called TAB014

    intravitreal injection at 1.25mg once every 4 weeks

  • Ranibizumab Injection [Lucentis]Drug

    Also called Lucentis

    intravitreal injection at 0.5mg once every 4 weeks

Study groups in NCT05461339
Study groupRoleWhat they receive
TAB014Experimentalintravitreal injection at 1.25mg once every 4 week
Receives: Drug: TAB014 Monoclonal Antibody Injection
RanibizumbActive comparatorintravitreal injection at 0.5mg once every 4 week
Receives: Drug: Ranibizumab Injection [Lucentis]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At week 52

Secondary outcomes (5)

  1. Evaluate the change in BCVA of the study eye

    Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart

    Measured: At week 12, 24 and 36

  2. Evaluate the proportion of subjects with an increase in BCVA of >5, >10, and >15 in the study eye

    Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart

    Measured: At week 12, 24 and 52

  3. 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

    Measured: At week 12, 24 and 52

  4. Change in central subfield thickness（CST) in the study eye

    CST measured by SD-OCT as assessed by independent central reading center

    Measured: At week 12, 24, 36 and 52

  5. Change in Choroidal Neovascularization (CNV) area of study eye

    CNV as assessed by independent central reading center

    Measured: At week 12, 24 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start28 Jun 2022
  3. Primary completion20 Sep 2024
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
488 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461339
Sponsor's protocol ID
TOT-CR-TAB014-III-01
Acronym
nAMD
Status last verified
Jan 2025
First submitted
12 Jul 2022
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAB014 Monoclonal Antibody Injection and Ranibizumab Injection [Lucentis] in people with Neovascular Age-related Macular Degeneration, run by BioDlink Biopharm Co., Ltd. at 56 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups. (time frame: At week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05461339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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