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Monoclonal Antibodies

HLX04-O vs Ranibizumab for Wet Age-Related Macular Degeneration

Phase 3
Recruiting
Research Sponsored by Shanghai Henlius Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable to understand and sign the informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Women or men aged ≥50 years when signing the ICF.
Timeline
Screening 1 day
Treatment 12 months
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trialcompares the effects of two treatments for wet age-related macular degeneration.

Who is the study for?
This trial is for men and women aged 50 or older with newly diagnosed, untreated wet Age-Related Macular Degeneration (wAMD) affecting the central part of their retina. Participants must have a certain level of vision clarity and be able to complete all study visits. They cannot join if they've had recent eye surgery, uncontrolled diseases like high blood pressure or diabetes, severe nearsightedness, or are pregnant/breastfeeding without using effective contraception.
What is being tested?
The trial is testing HLX04-O against ranibizumab, both administered through an injection into the eye to treat wAMD. The goal is to compare how well each treatment works and their safety profiles in patients who have this condition.
What are the potential side effects?
Potential side effects from treatments like HLX04-O and ranibizumab can include redness or discomfort at the injection site in the eye, increased intraocular pressure, inflammation inside the eye, bleeding in the retina area, cataract formation, and possibly others depending on individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and agree to the study's requirements by signing the consent form.
Select...
I am 50 years old or older.
Select...
I have new, untreated wet AMD affecting my central vision.
Select...
The damaged area in my eye is small enough for the study.

Timeline

Screening ~ 1 day
Treatment ~ 12 months
Follow Up ~12 months
This trial's timeline: 1 day for screening, 12 months for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline in BCVA at at Week 36
Secondary study objectives
Change from baseline in NEI VFQ-25 scale score at Week 12, 36, and 48.
Key : Mean change from baseline in BCVA at Week 48.
Mean change in BCVA over time
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HLX04-OExperimental Treatment1 Intervention
Biologic recombinant anti-VEGF humanized monoclonal antibody
Group II: RanibizumabActive Control1 Intervention
Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Find a Location

Who is running the clinical trial?

Shanghai Henlius BiotechLead Sponsor
88 Previous Clinical Trials
16,346 Total Patients Enrolled

Media Library

Age-Related Macular Degeneration Clinical Trial 2023: HLX04-O Highlights & Side Effects. Trial Name: NCT04740671 — Phase 3
~90 spots leftby Nov 2025
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