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

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema

Treatments: Drug: Aflibercept 8 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06491914

VGFTe-HD-OD-2444

Details and patient eligibility

About

This study is researching an experimental drug called aflibercept 8 mg, referred to as "study drug". 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 8 mg 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria for Participants with nAMD:

1. ≥50 years of age

2. Choroidal neovascularization (CNV) lesions secondary to nAMD, requiring anti-VEGF treatment per investigator.

   Key Inclusion Criteria for Participants with DME:

3. ≥18 years of age

4. DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye as determined by the investigator

   Key Inclusion for All Participants:

5. Previously treated with ≥3 anti-VEGF IVT injections 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 Exclusion Criteria for Participants with DME:

2. Evidence of macular edema due to any other cause other than diabetes mellitus

3. Active proliferative DR in the study eye

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Aflibercept 8 mg

Experimental group

Description:

Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications

Treatment:

Drug: Aflibercept 8 mg