MedTrace Logo

Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

NCT04423718 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1011

Last updated 2025-08-29

Study results available
· View outcomes & findings →

Summary

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Conditions

  • Neovascular Age-Related Macular Degeneration

Interventions

DRUG

Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)

Solution in Vial, intravitreal (IVT) injection

DRUG

Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)

Solution in Vial, 2 mg, intravitreal (IVT) injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2022-07-27
Completion
2024-08-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Estonia
  • France
  • Georgia
  • Hungary
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Portugal
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423718 on ClinicalTrials.gov