Clinical trial NCT01448538: Non-Persistence/Non-Adherence (NP/NA) in Wet Age-related Macular Degeneration (wAMD) Patients in Germany
Official title: Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Macular Degeneration
Keywords: Medication Non-Adherence
Medication Persistence
wet macular degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German wAMD patients with Anti-VEGF therapy included by centers responsible for intravitreal injections

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient has wet age-related macular degeneration (wAMD)
* Patient has already received at least one Anti-VEGF injection
* From a clinical standpoint, if there is an ophthalmological need for treatment it is probable that the patient gets additional anti-VEGF injections in the next year.
* The patient is able and willing to take part in the study (answering a short questionnaire in the study centre, 4 independent phone interviews during study period).

Exclusion Criteria:

* At time of inclusion visit, the study centre is only exceptionally responsible for the treatment of the patient.
* The patient is taking part in another study.

Primary outcomes:
measure: 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
timeFrame: 12 months after a patient was included into the study
Secondary outcomes:
measure: 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
timeFrame: 12 months after inclusion of patients
measure: Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)
timeFrame: Measurement during patient interviews about 4/8 months after inclusion
measure: Identifying NA/NP outcomes (assessed by visual acuity)
timeFrame: Every eye doctors visit between inclusion of patients and their exclusion
measure: Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes
timeFrame: Measurement during patient interview after about 11 months after inclusion
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: