ABP 938 8 mg vs EYLEA® HD (aflibercept) in neovascular AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 study compares ABP 938 8 mg to aflibercept 8 mg in treatment‑naïve neovascular AMD. Participants have active subfoveal CNV with fluid affecting the central retina and meet specific vision and lesion criteria. The main outcome is change in best corrected visual acuity to determine similarity in efficacy, with safety and immunogenicity also monitored. Treatments are given via intravitreal injections and outcomes are assessed using SD‑OCT and standard eye exams. The study is sponsored by Amgen and is conducted at select retina clinics in California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men or women ≥ 50 years old, capable of giving signed informed consent
* Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
* Total area of CNV (including both classic and occult components) \> 50% of the total lesion area in the SE
* The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
* Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:

* Total lesion size \> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
* Scar, fibrosis, or atrophy involving the central subfield in the study eye
* Scar or fibrosis involving \> 50% of the total lesion in the study eye
* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study
* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study
* Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye
* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye
* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization
* Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening
* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins
* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation
* Other protocol-specified exclusion criteria

Where it's running

• Retina Consultants of Orange County
  Fullerton, California, United States Recruiting
• South Coast Retina Center - RCA
  Long Beach, California, United States Recruiting
• Retinal Consultants Medical Group, Inc - Modesto (RCA)
  Modesto, California, United States Recruiting
• California Eye Specialists Medical Group, Inc
  Pasadena, California, United States Recruiting
• Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
  Sacramento, California, United States Recruiting
• California Retina Consultants
  Santa Barbara, California, United States Recruiting

+31 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.