Trials / Completed
CompletedNCT01363440
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 466 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) | |
| PROCEDURE | Macular Laser Photocoagulation | Laser therapy |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2013-01-01
- Completion
- 2014-11-01
- First posted
- 2011-06-01
- Last updated
- 2016-05-30
- Results posted
- 2015-04-20
Locations
51 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01363440. Inclusion in this directory is not an endorsement.