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Completed Phase 3 Interventional Results available

Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema

ClinicalTrials.gov ID: NCT01363440

Public ClinicalTrials.gov record NCT01363440. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 11:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema

Study identification

NCT ID
NCT01363440
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
466 participants

Conditions and interventions

Interventions

  • Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) Drug
  • Macular Laser Photocoagulation Procedure

Drug · Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2011
Primary completion
Dec 31, 2012
Completion
Oct 31, 2014
Last update posted
May 29, 2016

2011 – 2014

United States locations

U.S. sites
51
U.S. states
23
U.S. cities
51
Facility City State ZIP Site status
Not listed Phoenix Arizona
Not listed Tucson Arizona
Not listed Arcadia California
Not listed Beverly Hills California
Not listed La Jolla California
Not listed Mountain View California
Not listed Oakland California
Not listed Palm Desert California
Not listed Sacramento California
Not listed San Francisco California
Not listed Santa Barbara California
Not listed Torrance California
Not listed Colorado Springs Colorado
Not listed Golden Colorado
Not listed New London Connecticut
Not listed Fort Lauderdale Florida
Not listed Fort Myers Florida
Not listed Miami Florida
Not listed Orlando Florida
Not listed Winter Haven Florida
Not listed Augusta Georgia
Not listed ‘Aiea Hawaii
Not listed Wichita Kansas
Not listed Portland Maine
Not listed Baltimore Maryland
Not listed Boston Massachusetts
Not listed Missoula Montana
Not listed Las Vegas Nevada
Not listed New Brunswick New Jersey
Not listed Northfield New Jersey
Not listed Teaneck New Jersey
Not listed Lynbrook New York
Not listed Orchard Park New York
Not listed Rochester New York
Not listed Asheville North Carolina
Not listed Charlotte North Carolina
Not listed Raleigh North Carolina
Not listed Portland Oregon
Not listed Kingston Pennsylvania
Not listed Pittsburgh Pennsylvania
Not listed Florence South Carolina
Not listed West Columbia South Carolina
Not listed Rapid City South Dakota
Not listed Nashville Tennessee
Not listed Abilene Texas
Not listed Austin Texas
Not listed Harlingen Texas
Not listed Houston Texas
Not listed San Antonio (2 Locations) Texas
Not listed The Woodlands Texas
Not listed Salt Lake City Utah

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01363440, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 29, 2016 · Synced Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01363440 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →