A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.

The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emanuelli Research and Development Center, Arecibo, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria for Participants with nAMD:

≥50 years of age
History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.

Key Inclusion Criteria for Participants with DME:

≥18 years of age
History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator

Key Inclusion for All Participants:

Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1

Key Exclusion Criteria for Participants with nAMD:

Evidence of CNV due to any cause other than nAMD in either eye

Key Exclusion Criteria for Participants with DME:

Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
Active proliferative diabetic retinopathy (DR) in the study eye

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Treatment and study plan

aflibercept 8 mg

Drug

Administered by intravitreal (IVT) injection

Other names: EYLEA®HD, BAY86-5321

Primary outcomes

Occurrence of treatment-emergent adverse events (TEAEs)

Time frame: Through week 24
Occurrence of serious TEAEs

Time frame: Through week 24

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Acronym: ELARA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2027
First posted: Jul 9, 2024
Registry last updated: Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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