Trials / Completed
CompletedNCT01331681
Intravitreal Aflibercept Injection in Vision Impairment Due to DME
A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 406 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VEGF Trap-Eye (BAY86-5321) | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| BIOLOGICAL | VEGF Trap-Eye (BAY86-5321) | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8). |
| PROCEDURE | Macular Laser Photocoagulation (Control) | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
Timeline
- Start date
- 2011-05-09
- Primary completion
- 2013-06-03
- Completion
- 2015-03-30
- First posted
- 2011-04-08
- Last updated
- 2023-11-27
- Results posted
- 2014-09-09
Locations
73 sites across 11 countries: Australia, Austria, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Poland, Spain
Source: ClinicalTrials.gov record NCT01331681. Inclusion in this directory is not an endorsement.