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) (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 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.

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. 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 Exclusion Criteria for Participants with DME:

2. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye

3. Active proliferative diabetic retinopathy (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)

---

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