HLX04-O vs Ranibizumab for Wet Age-Related Macular Degeneration
Recruiting at 134 trial locations
QJ
Overseen ByQi Jin, Bachelor
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Shanghai Henlius Biotech
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
I have new, untreated wet AMD affecting my central vision.
The damaged area in my eye is small enough for the study.
My eyes can be clearly photographed for diagnosis.
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Exclusion Criteria
Fertile women or men fail to meet either of the following ones: 1) women of childbearing potential must have a negative urine or serum pregnancy test result within 14 days prior to initiation of the study intervention, and should not breastfeed. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of study intervention. Effective contraceptive methods with a failure rate of <1% per year, including bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices (IUDs), and copper IUDs.
My other eye needs an anti-VEGF injection soon, as per my doctor's advice.
My eye has a history of specific conditions like corneal dystrophy or retinal detachment.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive HLX04-O or Ranibizumab via intravitreal injection
48 weeks
Regular visits for injections and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- HLX04-O
- ranibizumab
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: HLX04-OExperimental Treatment1 Intervention
Group II: RanibizumabActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Henlius Biotech
Lead Sponsor
Trials
100
Recruited
19,200+
Dr. Jason Zhu
Shanghai Henlius Biotech
Chief Executive Officer since 2023
MBA from Yale University
Dr. Jun Zhu
Shanghai Henlius Biotech
Chief Medical Officer
MD from an unspecified institution
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