Trials / Completed
CompletedNCT02924311
Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 402 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients). This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results. |
Timeline
- Start date
- 2016-09-21
- Primary completion
- 2019-08-12
- Completion
- 2019-12-06
- First posted
- 2016-10-05
- Last updated
- 2023-11-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02924311. Inclusion in this directory is not an endorsement.