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

NCT01448538 | Completed DMC

• 2 other identifiers: 15785HE-WAMD-01
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Macular Degeneration

Keywords

Medication Non-Adherence; Medication Persistence; wet macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)

  Measurement during patient interviews about 4/8 months after inclusion

• Identifying NA/NP outcomes (assessed by visual acuity)

  Every eye doctors visit between inclusion of patients and their exclusion

• Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes

  Measurement during patient interview after about 11 months after inclusion

Study Arms (1)

Group 1

Drug: Anti-VEGF injections

Interventions

Anti-VEGF injections DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

German wAMD patients with Anti-VEGF therapy included by centers responsible for intravitreal injections

You may qualify if:

• 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).

You may not qualify if:

• The patient is taking part in another study.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Wet Macular Degeneration; Medication Adherence

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 7, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 14, 2015

Record last verified: 2015-09

Locations

DE (1)