Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.
Study identification
- NCT ID
- NCT01363440
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 466 participants
Conditions and interventions
Conditions
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
- May 2011 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Nov 2014 (Actual)
- Last update posted
- May 30, 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 30, 2016 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01363440 live on ClinicalTrials.gov.