Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ACTIVE_NOT_RECRUITING

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)

Lead Sponsor:

Regeneron Pharmaceuticals

Conditions:

Neovascular Age-Related Macular Degeneration

Diabetic Macular Edema

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • Key Inclusion Criteria for Participants with nAMD:
  • ≥50 years of age
  • 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:
  • ≥18 years of age
  • 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:
  • 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:
  • Evidence of CNV due to any cause other than nAMD in either eye
  • Key Exclusion Criteria for Participants with DME:
  • Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
  • Active proliferative diabetic retinopathy (DR) in the study eye
  • NOTE: Other protocol defined inclusion / exclusion criteria apply.

Exclusion

    Key Trial Info

    Start Date :

    July 24 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 7 2027

    Estimated Enrollment :

    1118 Patients enrolled

    Trial Details

    Trial ID

    NCT06491914

    Start Date

    July 24 2024

    End Date

    January 7 2027

    Last Update

    October 15 2025

    Active Locations (54)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (54 locations)

    1

    Win Retina - Arcadia

    Arcadia, California, United States, 91006

    2

    California Retina Consultants

    Bakersfield, California, United States, 93309

    3

    Retina Specialists of Beverly Hills

    Beverly Hills, California, United States, 90212

    4

    Salehi Retina Institute dba Retina Associates of Southern California

    Huntington Beach, California, United States, 92647