Trials / Completed
CompletedNCT02818998
Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)
An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema (DME)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 463 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
Timeline
- Start date
- 2016-11-16
- Primary completion
- 2018-11-13
- Completion
- 2019-09-24
- First posted
- 2016-06-30
- Last updated
- 2020-07-31
- Results posted
- 2019-12-04
Locations
64 sites across 14 countries: Austria, Canada, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02818998. Inclusion in this directory is not an endorsement.