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A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

NCT04740671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-01-03

No results posted yet for this study

Summary

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

Conditions

  • Age Related Macular Degeneration

Interventions

DRUG

HLX04-O

Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.

DRUG

ranibizumab

Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Serbia
  • Singapore
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04740671 on ClinicalTrials.gov