Trials / Completed
CompletedNCT01783886
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
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
- 381 (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 | Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| BIOLOGICAL | Aflibercept (Eylea, 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 | 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
- 2013-02-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2013-02-05
- Last updated
- 2016-05-12
- Results posted
- 2016-04-05
Locations
25 sites across 4 countries: China, Hong Kong, Russia, South Korea
Source: ClinicalTrials.gov record NCT01783886. Inclusion in this directory is not an endorsement.