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

NCT05461339 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2025-01-07

No results posted yet for this 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).

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

TAB014 Monoclonal Antibody Injection

intravitreal injection at 1.25mg once every 4 weeks

DRUG

Ranibizumab Injection [Lucentis]

intravitreal injection at 0.5mg once every 4 weeks

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    collaborator INDUSTRY

  • BioDlink Biopharm Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Youxin Chen, PhD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-09-20
Completion
2025-02-28
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461339 on ClinicalTrials.gov