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)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06491914

Acronym

ELARA

Enrollment

1126

Registered

2024-07-09

Start date

2024-07-24

Completion date

2027-01-07

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration

Brief summary

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.

Interventions

DRUGAflibercept 8 mg

Administered by intravitreal (IVT) injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria for Participants with nAMD: 1. ≥50 years of age 2. 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: 3. ≥18 years of age 4. 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: 5. 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: 1. Evidence of CNV due to any cause other than nAMD in either eye Key

Design outcomes

Primary

Measure	Time frame
Participants With at Least One Treatment-emergent Adverse Event (TEAE)	Through week 24
Participants With at Least One Serious TEAE	Through week 24

Countries

Puerto Rico, United States

Contacts

STUDY_DIRECTORClinical Trial Management

Regeneron Pharmaceuticals

Participant flow

Recruitment details

1376 participants screened. 1126 participants enrolled. 1110 participants treated.

Baseline characteristics

Characteristic	—
Age, Continuous	77.1 years STANDARD_DEVIATION 8.5
Ethnicity (NIH/OMB) Hispanic or Latino	114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	371 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	59 Participants
Race (NIH/OMB) Black or African American	51 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants
Race (NIH/OMB) White	976 Participants
Sex: Female, Male Female	563 Participants
Sex: Female, Male Male	262 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 625	4 / 501
other Total, other adverse events	0 / 625	0 / 501
serious Total, serious adverse events	34 / 625	40 / 501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026