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ACTIVE NOT RECRUITING Phase 3

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)

NCT06491914 · View on ClinicalTrials.gov ↗

Study 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

  • DRUG Aflibercept 8 mg

Study Locations (20)

Florida

  • Advanced Research, LLC — Deerfield Beach
  • Florida Retina Institute - Jacksonville — Jacksonville
  • Florida Retina Consultants — Lakeland
  • Florida Retina Institute - Orlando — Orlando
  • Retina Speciality Institute - Pensacola, Florida — Pensacola
  • Eye Associates of Pinellas — Pinellas Park
  • Retina Vitreous Associates of Florida Saint Petersburg — St. Petersburg
  • Retina Vitreous Associates of Florida — Tampa
  • Center for Retina and Macular Disease — Winter Haven

California

  • Win Retina - Arcadia — Arcadia
  • California Retina Consultants — Bakersfield
  • Retina Specialists of Beverly Hills — Beverly Hills
  • Salehi Retina Institute dba Retina Associates of Southern California — Huntington Beach
  • South Coast Retina Center — Long Beach
  • California Eye Specialists Medical Group, Inc. — Pasadena
  • Retina Consultants of Southern California — Redlands
  • Vrmg Inc — Sacramento

Colorado

  • Retina Consultants of Southern Colorado — Colorado Springs
  • Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute — Longmont

Connecticut

  • Retina Group of New England — Waterford

Trial Details

FieldValue
Enrollment Target 1,118 participants
Start Date 2024-07-24
Est. Completion 2027-01-07
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06491914

The ClinicalTrials.gov registry entry for NCT06491914 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention — of which Aflibercept 8 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06491914 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06491914 about?

NCT06491914 is a clinical study titled "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...

What is the current status of trial NCT06491914?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,118 participants. The study started on 2024-07-24. Estimated completion is 2027-01-07.

What conditions does trial NCT06491914 study?

This clinical trial studies the following conditions: Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06491914?

The interventions under investigation include: Aflibercept 8 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06491914?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06491914 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial