A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

Recruiting at 138 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Diabetes, Hypertension, Cardiovascular, 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: 56

Duration: 48 weeks

576 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two drugs, ABP 938 and Aflibercept, for treating patients with a serious eye condition called neovascular age-related macular degeneration. The drugs are injected into the eye to stop harmful blood vessel growth and protect vision. Aflibercept is designed to target specific growth factors involved in this condition.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain treatments for neovascular AMD and some other medications are not allowed before joining the study. It's best to discuss your current medications with the study team to see if they are permitted.

What safety data exists for Aflibercept (also known as ABP 938, Eylea, Zaltrap) in humans?

Aflibercept has been studied for safety in conditions like diabetic macular edema and metastatic colorectal cancer. Common side effects include those related to anti-VEGF treatments, such as increased risk of bleeding and high blood pressure, especially when combined with chemotherapy. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Inclusion Criteria

Central retinal thickness of > 270µm in the study eye as measured by the machine, calculated average thickness in the central 1 mm subfield (CST) by SD-OCT at screening

Subjects or their legally authorized representative must sign an Institutional Review Board/Independent Ethics Committee approved informed consent form before any study-specific procedures

Men or women ≥ 50 years old

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive either ABP 938 or aflibercept by intravitreal injection, with re-randomization at week 16

48 weeks

Injections every 4 weeks initially, then every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

End of study visit at week 52

Treatment Details

Interventions

• ABP 938
• Aflibercept

Participant Groups

Group I: ABP 938-Treatment Group A Experimental Treatment 1 Intervention

Subjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48.

Group II: ABP 938-Treatment group B2 Active Control 2 Interventions

Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48

Group III: Aflibercept-Treatment Group B1 Active Control 1 Intervention

Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48.

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

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

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

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Findings from Research

Intravitreal aflibercept significantly improved visual acuity in patients with diabetic macular oedema compared to macular laser photocoagulation and other treatments like bevacizumab and ranibizumab, particularly in those with worse baseline vision, as shown in phase III trials.

Aflibercept was generally well tolerated, making it a promising and effective new treatment option for diabetic macular oedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Keating, GM.[2022]

Aflibercept, an anti-angiogenic drug, was approved in Europe for use with FOLFIRI in adults with metastatic colorectal cancer that has progressed after oxaliplatin treatment, showing improved overall survival (13.5 months vs 12.06 months) in the VELOUR Phase III trial.

While aflibercept enhances survival rates, it also increases the risk of specific side effects related to anti-VEGF therapy and some chemotherapy-related toxicities, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aflibercept (Zaltrap(®)) approved in metastatic colorectal cancer]. André, T., Chibaudel, B.[2013]

In a study of 26 patients with refractory diabetic macular edema (DME), ziv-aflibercept treatment led to significant improvements in visual acuity and macular thickness after switching from previous anti-VEGF therapies.

No adverse ocular or systemic side effects were reported, indicating that ziv-aflibercept is a safe option for patients who did not respond to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. Ashraf, M., Kayal, HE., Souka, AAR.[2022]

A study involving 12 patients showed that a single intravitreal injection of ziv-aflibercept for treating choroidal neovascularization due to age-related macular degeneration was safe, with no serious ocular or systemic adverse events reported after 30 days.

While there was only a slight improvement in best-corrected visual acuity after treatment, the absence of significant side effects suggests that ziv-aflibercept could be a viable low-cost alternative for macular disease therapy, especially in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. Chhablani, J., Narayanan, R., Mathai, A., et al.[2022]

Aflibercept, a drug that blocks VEGF receptors, was shown to improve overall survival in patients with metastatic colorectal cancer, with a median survival of 13.5 months compared to 12.1 months for those receiving a placebo, based on a study of 1226 patients.

While aflibercept demonstrated efficacy in extending survival, it also had a higher frequency of adverse events compared to placebo, highlighting the importance of monitoring for side effects when using anti-VEGF therapies in combination with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. Stanel, SC., Sjöberg, J., Salmonson, T., et al.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Aflibercept (Zaltrap(®)) approved in metastatic colorectal cancer]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. [2022]

5. England pubmed.ncbi.nlm.nih.gov

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. [2021]