Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

Completed · Phase 3

Conditions studied: Neovascular Age-Related Macular Degeneration

In brief

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Key facts

Study ID

NCT04423718

Run by

Bayer

People needed

1011

Starts

2020-08-11

Expected to finish

2024-08-07

Last updated by the study team

2025-08-29

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
• Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
• BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
• Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
• Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
• Other protocol-specified inclusion criteria.
• Additional inclusion criteria for Year 3:
• At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
• Participant is enrolled at a site that participates in the extension period.

You may not qualify if…

• Causes of CNV other than nAMD in the study eye.
• Scar, fibrosis, or atrophy involving the central subfield in the study eye.
• Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
• Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
• History of idiopathic or autoimmune uveitis in the study eye.
• Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
• History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
• Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
• Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
• Other protocol-specified exclusion criteria

Where it is running

• Retina Consultants of Orange County - Fullerton — Fullerton, California, United States
• Northern California Retina Vitreous Associates - Mountain View Office — Mountain View, California, United States
• Azul Vision Pasadena — Pasadena, California, United States
• Retina Consultants San Diego - Poway — Poway, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Kaiser Permanente Riverside Medical Center - Cardiology — Riverside, California, United States
• Perlman Medical Offices at UC San Diego Health - Endocrinology — San Diego, California, United States
• Retina Consultants of Southern Colorado, PC — Colorado Springs, Colorado, United States
• New England Retina Associates — New London, Connecticut, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Retina Group of Florida - Fort Lauderdale — Fort Lauderdale, Florida, United States
• Vitreo Retinal Associates PA - The Millennium Center Location — Gainesville, Florida, United States
• Florida Retina Institute- Jacksonville Oak — Jacksonville, Florida, United States
• Florida Eye Associates - Melbourne Main Office — Melbourne, Florida, United States
• Retina Macula Specialists Of Miami - LeJeune Road Office — Miami, Florida, United States
• Florida Retina Institute - Orlando — Orlando, Florida, United States
• Retina Specialty Institute - Pensacola — Pensacola, Florida, United States
• Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg, Florida, United States
• Southern Vitreoretinal Associates, P.L. - Tallahassee — Tallahassee, Florida, United States
• Retina Consultants of Hawaii - Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• Retina Associates IL — Elmhurst, Illinois, United States
• University Retina and Macula Associates — Oak Forest, Illinois, United States
• Wolfe Eye Clinic - Des Moines — West Des Moines, Iowa, United States
• The Retina Care Center - Baltimore — Baltimore, Maryland, United States
• Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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