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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in BCVA at at Week 36
Secondary outcome measures
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

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
87 Previous Clinical Trials
15,350 Total Patients Enrolled

Media Library

Age-Related Macular Degeneration Clinical Trial 2023: HLX04-O Highlights & Side Effects. Trial Name: NCT04740671 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health condition is A commonly prescribed for?

"A is a common remedy for retinal vein occlusion and can also be used to address wet age-related macular degeneration (wAMD), macular edema, myopic choroidal neovascularization."

Answered by AI

What other exploratory studies have been conducted with regard to A?

"Currently, there are 30 research projects being conducted on A. Of those trials, 16 have entered Phase 3. While the majority of studies for this medication occur in Royal Oak, Michigan; worldwide 1023 medical sites are participating in these investigations."

Answered by AI

What number of participants has been recruited for this experiment?

"Affirmative. The details available on clinicaltrials.gov suggest that this medical trial is actively enrolling participants; it was originally posted on April 7th 2022 and the latest update occurred December 21st 2022, when 388 volunteers were sought at 1 specific site."

Answered by AI

To what extent is A a reliable treatment option for patients?

"According to our team at Power, the safety of A is rated highly due to this being a Phase 3 trial. This indicates that there has been extensive data gathered regarding both efficacy and safety."

Answered by AI

Are individuals presently being enlisted for this medical experiment?

"According to clinicaltrials.gov, this research is actively enlisting participants; the trial was first announced on April 7th 2022 and has been recently amended on December 21st of that same year."

Answered by AI

What goals are researchers aiming to accomplish with this experiment?

"This trial will assess the Mean change from baseline in BCVA at Week 36 as its primary outcome over a lengthy 9 month time frame. Secondary outcomes include gauging the Proportion of patients gaining at least 5 letters in their BCVA at Months 3, 9 and 12, determining the Mean change from baseline in BCVA over time, and further measuring the Proportion of participants who experience an increase by 10 or more letters to their BCVA scores across those same months; all detailed measurements can be found within the Statistical Analysis Plan."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
California
What site did they apply to?
VMR Institute
South Coast Retina Center
University of South Florida
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I have dry AMD (GA) in both eyes and wet in my right. I really need to stop smoking for my health and grandbabies.
PatientReceived 1 prior treatment
My dad had macular degeneration as well as his three siblings.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD
2021. "A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740671.
All > Age Related Macular Degeneration > Macular Degeneration
~42 spots leftby Aug 2024
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