Ireland
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Active, not recruiting Phase 3

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

NCT05461339 · tracked via the Priya Life Science China tracker
Sponsor
BioDlink Biopharm Co., Ltd
Phase
Phase 3
Started
2022-06-28
Last updated
2025-01-07

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

TAB014 Monoclonal Antibody InjectionRanibizumab Injection [Lucentis] →

TAB014 Monoclonal Antibody Injection: intravitreal injection at 1.25mg once every 4 weeks

Ranibizumab Injection [Lucentis]: intravitreal injection at 0.5mg once every 4 weeks

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

Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (56)

FacilityCityRegionStatus
The Second Hospital of Anhui Medical University Hefei Anhui
Beijing Aier Intech Eye Hospital Beijing Beijing Municipality
Peking University People'S Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Beijing Hospital Beijing Beijing Municipality
Beijing Tongren Hospital, Cmu Beijing Beijing Municipality
The First Hospital of Jilin University Jilin City Changchun
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
Guangzhou First People's Hospital Guangzhou Guangdong
The Second Affiliated Hospital of Guangzhou Medical Guangzhou Guangdong
Zhongshan Ophthalmic Center, Sun Yat-Sen University Guangzhou Guangdong
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong Shantou Guangdong
Shenzhen Aier Eye Hospital Shenzhen Guangdong
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
Affiliated Hospital of Zunyi Medical University Zunyi Guizhou
Cangzhou Central Hospital Cangzhou Hebei
Hebei Eye Hospital Xingtai Hebei
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
Kaifeng Central Hopital Kaifeng Henan
Henan Eye Hospital& Henan Eye Institute Zhengzhou Henan
Zhengzhou Second Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) Shiyan Hubei
Tongji Hospital® Tongji Medical Collehe of Hust Wuhan Hubei
Renmin Hospital of Wuhan University Wuhan Hubei
Central theater General Hospital Wuhan Hubei
Wuhan Puren Hospital Wuhan Hubei
Hunan Provincial People's Hospital Changsha Hunan
Xiangya Hospital of Central South University Changsha Hunan
Aier Eye Hospital(Changsha) Changsha Hunan
Wuxi No.2 People's Hospital Wuxi Jiangsu
Affiliated Eye Hospital of Nanchang University Nanchang Jiangxi
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
Dalian No.3 People'S Hospital Dalian Liaoning
The Fourth People's Hospital of Shenyang Shenyang Liaoning
Shenyang He Eye Hospital Shenyang Liaoning
Weifang Eye Hospital Co., Ltd. Weifang Shandong
Shanghai Eye Disease Prevention and Treatment Center Shanghai Shanghai Municipality

+ 16 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05461339 on ClinicalTrials.gov ↗ ← All trials in China