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

No longer recruiting at 143 trial locations

Overseen By Qi Jin, Bachelor

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Shanghai Henlius Biotech

Must not be taking: Corticosteroids, Anti-VEGF

Disqualifiers: Uncontrolled diabetes, Hypertension, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of a new treatment, HLX04-O, with ranibizumab for individuals with wet age-related macular degeneration (wAMD), a condition that impairs vision. Participants will receive one of the two treatments through an injection into the eye to assess effectiveness and safety. Those newly diagnosed with untreated wAMD affecting central vision and who have not received previous anti-VEGF injections may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the development of a potential new treatment option.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like systemic corticosteroids and anti-VEGF drugs are restricted before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HLX04-O is safe for people. Previous studies found that patients with wet age-related macular degeneration (wAMD) generally tolerated this treatment well. Patients received HLX04-O as an eye injection every four weeks and usually did not experience major problems.

Ranibizumab, the treatment being compared to HLX04-O in this trial, has already received FDA approval for wAMD, indicating it has passed safety tests and is generally considered safe for people.

Both treatments have demonstrated promising safety records in studies. However, anyone considering joining a clinical trial should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about HLX04-O because it is a biologic recombinant anti-VEGF humanized monoclonal antibody that promises to offer a fresh approach to treating wet age-related macular degeneration (AMD). Unlike ranibizumab, the current standard of care, HLX04-O may provide improved efficacy or safety due to differences in structure or formulation. This innovation could mean more effective management of AMD, potentially leading to better vision outcomes for patients.

What evidence suggests that this trial's treatments could be effective for wet age-related macular degeneration?

This trial will compare HLX04-O with Ranibizumab for treating wet age-related macular degeneration (wAMD). Research shows that HLX04-O, which participants in this trial may receive, may help treat wAMD. Early results indicate that HLX04-O is safe and effective for people with wAMD by blocking VEGF, a protein that causes unwanted blood vessel growth in the eye.

Ranibizumab, another treatment option in this trial, is a well-known treatment for wAMD. Studies have shown it can improve vision and reduce fluid in the eye. Both treatments aim to improve vision by targeting VEGF in people with wAMD. ^{1 2 3 6 7}

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.

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.

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?

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

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9453407/

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF ...

HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient, demonstrating promising safety and efficacy in wAMD treatment.

2.

henlius.com

henlius.com/en/NewsDetails-4247-26.html

Henlius completed the phase 1/2 clinical trial of HLX04-O ...

The results showed that HLX04-O was safe and well tolerated in wAMD patients, and preliminary efficacy was observed.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04740671

NCT04740671 | A Phase 3 Study to Compare the Efficacy ...

This is a Phase 3, Randomized, Double-masked, Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05003245

NCT05003245 | Compare the Efficacy and Safety of HLX04 ...

this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD. Detailed ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36124180/

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF ...

HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient, demonstrating promising safety and efficacy in wAMD treatment ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04993352?tab=table

Evaluate the Safety and Efficacy of HLX04-O in Subjects ...

This is a Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in ...

7.

henlius.com

henlius.com/en/NewsDetails-4942-26.html

Primary Endpoint Met in Phase 3 Clinical Study of Henlius ...

The primary endpoint of this study was met, with the mean change in BCVA from baseline at week 48 in the HLX04-O group being non-inferior to that in the ...