Home
Clinical Trials
TAB014 Compared to Lucentis®...

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

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab in Patients With wAMD

NCT05480293

Wet Age-related Macular Degeneration

UNKNOWN PHASE3

Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients

NCT00826371

Age Related Macular Degeneration

COMPLETED PHASE3

Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

NCT04690556

Neovascular Age-related Macular Degeneration

COMPLETED PHASE3

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

NCT03805100

Macular Degeneration

COMPLETED PHASE3

Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration

NCT05439629

Neovascular (Wet) Age-related Macular Degeneration

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neovascular Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Subjects, investigators responsible for patient care, vision examiner (including BCVA assessors), research nurses, independent central reading center staff, and the sponsor are blinded. Unmasked pharmacist, unmasked nurse, unmasked treatment administration physician and unmasked research associates will take part in this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAB014

intravitreal injection at 1.25mg once every 4 week

Group Type EXPERIMENTAL

TAB014 Monoclonal Antibody Injection

Intervention Type DRUG

intravitreal injection at 1.25mg once every 4 weeks

Ranibizumb

intravitreal injection at 0.5mg once every 4 week

Group Type ACTIVE_COMPARATOR

Ranibizumab Injection [Lucentis]

Intervention Type DRUG

intravitreal injection at 0.5mg once every 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAB014 Monoclonal Antibody Injection

intravitreal injection at 1.25mg once every 4 weeks

Intervention Type DRUG

Ranibizumab Injection [Lucentis]

intravitreal injection at 0.5mg once every 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TAB014 Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Youxin Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.