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

Recruiting at134 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Shanghai Henlius Biotech

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Research Team

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• HLX04-O (Monoclonal Antibodies)
• ranibizumab (Monoclonal Antibodies)

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.

Participant Groups

Group I: HLX04-O Experimental Treatment 1 Intervention

Biologic recombinant anti-VEGF humanized monoclonal antibody

Group II: Ranibizumab Active Control 1 Intervention

Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

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