Non-Persistence/Non-Adherence (NP/NA) in Wet Age-related Macular Degeneration (wAMD) Patients in Germany
In the research study an observation of patients with wet age-related macular degeneration (wet AMD) will be performed.
The term observational study indicates that the current course of therapy and the associated circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs are tested.
This study is being conducted in about 30 centers in Germany. A total of approximately 500 patients will be enrolled. The study is designed for a period of 12 months.
At the beginning and end of the study the physician will document the patient data. Therefore will be used information from the patient records and documented visits. If such information is not available in the study center, the otherwise attending ophthalmologist will be consulted about the vision acuity values and visits in the observation period.
Furthermore, patients are asked to participate in three telephone interviews and fill out during their visits to the study center a short questionnaire about their current vision and their well-being. In the telephone interviews will be discussed with the patient about his wet AMD disease and its treatment, its experience and its perspectives as well as any problems occur.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences|
- Non-Persistence (NP) in the wAMD therapy in alternative study-specific definitions: (1) no eye exam for a period of at least 3 months OR (2) no 2 subsequent Anti-VEGF injections despite a clear medical need for injections [ Time Frame: 12 months after a patient was included into the study ] [ Designated as safety issue: No ]
- Extent of Non-Adherence (NA) in the Anti-VEGF-therapy in a study-specific definition: (1) no eye exam every 4th week OR (2) no Anti-VEGF injection despite a medical need for an injection [ Time Frame: 12 months after inclusion of patients ] [ Designated as safety issue: No ]
- Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences) [ Time Frame: Measurement during patient interviews about 4/8 months after inclusion ] [ Designated as safety issue: No ]
- Identifying NA/NP outcomes (assessed by visual acuity) [ Time Frame: Every eye doctors visit between inclusion of patients and their exclusion ] [ Designated as safety issue: No ]
- Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes [ Time Frame: Measurement during patient interview after about 11 months after inclusion ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2016|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Drug: Anti-VEGF injections
All Anti-VEGF injections approved for the German market, dosages as defined by doctors
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448538
|Many Locations, Germany|
|Study Director:||Bayer Study Director||Bayer|