304 Participants NeededMy employer runs this trial

ABP 938 vs Aflibercept for Age-Related Macular Degeneration

Recruiting at 65 trial locations
AC
Overseen ByAmgen Call Center
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 trial tests two treatments, ABP 938 and aflibercept, to determine their effectiveness for individuals with neovascular age-related macular degeneration (nAMD), a condition that can lead to vision loss. Researchers aim to measure how these treatments affect vision clarity over time. Participants will receive eye injections of either treatment and attend regular check-ups to adjust dosing based on their condition. This trial may suit individuals aged 50 and older who have been newly diagnosed with nAMD and experience fluid buildup in the eye that affects vision. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had prior or current treatment with certain eye medications or surgeries for the study eye. 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?

Previous studies have shown that ABP 938 is as safe as aflibercept for treating age-related macular degeneration (AMD). Research indicates no major safety differences between ABP 938 and aflibercept. Both treatments have similar side effects and are generally well-tolerated by patients. Participants in these studies did not experience unusual or severe side effects. This information provides confidence in the overall safety of ABP 938 for those considering joining a clinical trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ABP 938 for age-related macular degeneration (AMD) because it offers a promising alternative to standard treatments like Aflibercept. Unlike typical therapies that require frequent injections, ABP 938 is designed to potentially extend the interval between doses, offering patients more convenience and possibly better compliance. Additionally, ABP 938 targets similar pathways as existing options but may provide improved efficacy or safety, making it a hopeful option for those with AMD.

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

This trial will compare ABP 938 with Aflibercept for treating neovascular age-related macular degeneration (nAMD), which affects vision. Studies have shown that ABP 938 is as effective as Aflibercept in treating nAMD. Research indicates no major differences in how well these treatments improve eyesight. In one study, patients using ABP 938 improved by an average of 6.4 letters on a vision test by week 8. This finding suggests that ABP 938 is as effective as Aflibercept in helping people with nAMD maintain or improve their vision. Both treatments have been found safe and effective, with consistent results across multiple studies.12346

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for men and women aged 50 or older with a specific type of wet age-related macular degeneration in one eye that has not been treated before. Participants must have certain vision levels and active disease affecting the center of their vision.

Inclusion Criteria

My CNV covers more than half of the total lesion area in my eye.
I have new, untreated CNV in my study eye due to wet AMD affecting the center of vision.
I am at least 50 years old and able to give informed consent.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravitreal injections of either ABP 938 8 mg or Aflibercept 8 mg at Baseline, Week 4, and Week 8, with Dose Regimen Adjustment decisions starting at Week 16 based on disease-activity criteria

16 weeks
Injections at Baseline, Week 4, Week 8, and assessments at scheduled visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with injections administered at intervals ranging from every 4 to 16 weeks through the end of the study

Variable, up to end of study

What Are the Treatments Tested in This Trial?

Interventions

  • ABP 938 8 mg
  • Aflibercept (US) 8 mg

Trial Overview

The study compares two injections—ABP 938 (8 mg) and EYLEA HD (aflibercept, 8 mg)—to see if they work equally well at improving vision in people with neovascular age-related macular degeneration. Treatments are given by chance to participants.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ABP 938 8 mgExperimental Treatment1 Intervention
Group II: Aflibercept (US) 8 mgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

Randomized Trial of Biosimilar ABP 938 Compared with ...

To evaluate the clinical efficacy, safety, and immunogenicity of biosimilar ABP 938 compared with the aflibercept reference product (RP) in adults with ...

NCT04270747 | A Study to Understand Effectiveness and ...

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40769491/

Randomized Trial of Biosimilar ABP 938 Compared with ...

Conclusions: This study supports the conclusion of no clinically meaningful differences in efficacy, safety, and immunogenicity between ABP 938 ...

Biosimilar to Aflibercept ABP 938 Is Safe and Effective for ...

ABP 938 has shown similar clinical efficacy, safety, and immunogenicity to aflibercept in the treatment of neovascular age-related macular degeneration (nAMD).

Patients With nAMD Maintain Vision on Aflibercept ...

At week 8, patients treated with ABP 938 gained an average of 6.4 letters on the Early Treatment Diabetic Retinopathy Study scale compared with ...

A Study to Understand Effectiveness and Safety of ABP 938 ...

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age- ...