H35.8
Conditions
Interventions
Group 1: Adult patients suffering from visual impairment associated with chronic diabetic macular edema and for whom therapy is provided with an Iluvien implant shall be enrolled.
In the scope of the
Sponsors
Alimera Sciences Ophthalmologie GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - The patient (male / female) is at least 18 years old - The patient is treated with Iluvien® according to the summary of product characteristics - Treatment with Iluvien® is decided independently of the study - a written consent for study participation exists
Exclusion criteria
Exclusion criteria: contraindications according to the SmPC of Iluvien®, for example when the patient is suffering from a pre-existing glaucoma or an active or suspected infection of the eye or periocular region or known hypersensitivity to any component of Iluvien.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Influence of Iluvien® implant on visual acuity (ETDRS measurement ; at all 11 visits over a period of approximately 24 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Influence of Iluvien® implant on foveal thickness (measured by optical coherence tomography; at all 11 visits over a period of 24 months) - Influence of Iluvien® therapy on visual quality of life (measured by patient questionnaire NEI-VFQ-25; at Visit 1 (baseline / implantation), visit 4 (about 3 months after implantation), visit 5 (about 6 months after implantation), visit 7 (about 12 months after implantation) and visit 11 (about 24 months after implantation)) - Global assessment of Iluvien® therapy in patients with visual impairment in connection with diabetic macular edema (at Visit 11 (about 24 months after implantation)) | — |
Countries
Austria, Germany
Contacts
Public ContactFocke Ziemssen
Oberarzt der Universitäts-Augenklinik Tübingen
Outcome results
None listed