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Anti-VEGF

Aflibercept for Age-Related Macular Degeneration and Diabetic Macular Edema (ELARA Trial)

Phase 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with nAMD: ≥50 years of age, Choroidal neovascularization (CNV) lesions secondary to nAMD, requiring anti-VEGF treatment per investigator.
Participants with DME: ≥18 years of age, 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
Must not have
Participants with DME: Evidence of macular edema due to any other cause other than diabetes mellitus, Active proliferative DR in the study eye
Participants with nAMD: Evidence of CNV due to any cause other than nAMD in either eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new drug called aflibercept 8 mg on people with nAMD and DME who have already used other medications. The goal is to see how safe and effective the drug

Who is the study for?
This trial is for adults with nAMD or DME who have already tried other anti-VEGF treatments. It's not specified who can't join, but typically those with health issues that could interfere with the study or pose extra risks are excluded.
What is being tested?
The study tests aflibercept 8 mg injections in patients with nAMD and DME to assess safety and effectiveness. Participants will receive injections as often as every four weeks to monitor outcomes.
What are the potential side effects?
Potential side effects of aflibercept may include eye irritation, increased intraocular pressure, vision changes, bleeding inside the eye, and possible infection from the injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 50 with nAMD needing treatment for CNV lesions.
Select...
I am over 18 and have DME affecting the center of my retina.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My eye swelling is not due to diabetes but another cause.
Select...
I have CNV in my eye not caused by nAMD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aflibercept 8 mgExperimental Treatment1 Intervention
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,424 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,517 Total Patients Enrolled
~267 spots leftby Dec 2025
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