Non-Persistence/Non-Adherence (NP/NA) in Wet Age-related Macular Degeneration (wAMD) Patients in Germany

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: Anti-VEGF injections

• Registration Number: NCT01448538
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-11
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Anti-VEGF injections	-

Primary Outcome Measures

Name	Time	Method
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	12 months after a patient was included into the study

Secondary Outcome Measures

Name	Time	Method
Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes	Measurement during patient interview after about 11 months after inclusion
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	12 months after inclusion of patients
Identifying NA/NP outcomes (assessed by visual acuity)	Every eye doctors visit between inclusion of patients and their exclusion
Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)	Measurement during patient interviews about 4/8 months after inclusion