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

Wet Macular Degeneration Clinical Trial

Official title:

Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448538
• Other study ID #: 15785
• Secondary ID: HE-WAMD-01
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: September 11, 2015
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: September 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Anti-VEGF injections
All Anti-VEGF injections approved for the German market, dosages as defined by doctors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Identifying NA/NP outcomes (assessed by visual acuity)		Every eye doctors visit between inclusion of patients and their exclusion	No
Secondary	Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes		Measurement during patient interview after about 11 months after inclusion	No

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