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

TOT Biopharm Co., Ltd.56 sites in 1 country488 target enrollmentJune 28, 2022

ConditionsNeovascular Age-related Macular Degeneration

InterventionsTAB014 Monoclonal Antibody Injection Ranibizumab Injection [Lucentis]

DrugsTAB014 Monoclonal Antibody Injection Ranibizumab Injection [Lucentis]

Overview

Phase: Phase 3
Intervention: TAB014 Monoclonal Antibody Injection
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: TOT Biopharm Co., Ltd.
Enrollment: 488
Locations: 56
Primary Endpoint: Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups.
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

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.

Registry

clinicaltrials.gov

Start Date

June 28, 2022

End Date

February 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

TOT Biopharm Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;
•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;

Arms & Interventions

TAB014

intravitreal injection at 1.25mg once every 4 week

Intervention: TAB014 Monoclonal Antibody Injection

Ranibizumb

intravitreal injection at 0.5mg once every 4 week

Intervention: Ranibizumab Injection [Lucentis]

Outcomes

Primary Outcomes

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

Secondary Outcomes

Evaluate the change in BCVA of the study eye(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(At week 12, 24 and 52)
Evaluate the proportion of subjects with a BCVA loss of <5, <10, < 15 letters in the study eye(At week 12, 24 and 52)
Change in central subfield thickness（CST) in the study eye(At week 12, 24, 36 and 52)
Change in Choroidal Neovascularization (CNV) area of study eye(At week 12, 24 and 52)