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

Neovascular Age-related Macular Degeneration Clinical Trial

— nAMD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461339
• Other study ID #: TOT-CR-TAB014-III-01
• Status: Recruiting
• Phase: Phase 3
• Start date: June 28, 2022
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: TOT Biopharm Co., Ltd.
• Contact: Junping Hong, PhD
• Phone: 86-010-85979677
• Email: hongjunping[@]totbiopharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Xiamen Eye Center of Xiamen University	Amoy	Fujian
China	Beijing Aier Intech Eye Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tongren Hospital, Cmu	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University People'S Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Aier Eye Hospital(Changsha)	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhi People'S Hospital	Changzhi	Shanxi
China	Chengdu Aier Eye Hospital	Chengdu	Sichuan
China	Ineye Hospital of Chengdu University of TCM	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian No.3 People'S Hospital	Dalian	Liaoning
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical	Guangzhou	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yat-Sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The First Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)	Hangzhou	Zhejiang
China	Zhejiang Provincial People'S Hospital	Hangzhou	Zhejiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	The First Hospital of Jilin University	Jilin	Changchun
China	Jinan 2Nd People'S Hospital	Jinan	Shandong
China	The First People's Hospital of Jinzhong(Jinzhong Hospital Affiliated to Shanxi Medical University)	Jinzhong	Shanxi
China	Kaifeng Central Hopital	Kaifeng	Henan
China	Affiliated Eye Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital(Tenth People's Hospital of Tongji Unversity)	Shanghai	Shanghai
China	Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong	Shantou	Guangdong
China	Shenyang He Eye Hospital	Shenyang	Liaoning
China	The Fourth People's Hospital of Shenyang	Shenyang	Liaoning
China	Shenzhen Aier Eye Hospital	Shenzhen	Guangdong
China	Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)	Shiyan	Hubei
China	Shanxi Eye Hospital	Taiyuan	Shanxi
China	Tianjin Eye Hospital	Tianjin	Tianjin
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin
China	Weifang Eye Hospital Co., Ltd.	Weifang	Shandong
China	Eye Hospital, WMU	Wenzhou	Zhejiang
China	Central theater General Hospital	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital® Tongji Medical Collehe of Hust	Wuhan	Hubei
China	Wuhan Puren Hospital	Wuhan	Hubei
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu
China	Xi'An Fourth Hospital	Xi'an	Shanxi
China	Xi'an No.1 Hospital	Xi'an	Shanxi
China	Hebei Eye Hospital	Xingtai	Hebei
China	Henan Eye Hospital& Henan Eye Institute	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhengzhou Second Hospital	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
TOT Biopharm Co., Ltd.	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Evaluation	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
Other	Immunogenicity Evaluation	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
Primary	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	At week 52
Secondary	Evaluate the change in BCVA of the study eye	Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart	At week 12, 24 and 36
Secondary	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	At week 12, 24 and 52
Secondary	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	At week 12, 24 and 52
Secondary	Change in central subfield thickness(CST) in the study eye	CST measured by SD-OCT as assessed by independent central reading center	At week 12, 24, 36 and 52
Secondary	Change in Choroidal Neovascularization (CNV) area of study eye	CNV as assessed by independent central reading center	At week 12, 24 and 52