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NCT Number: NCT01448538

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-VEGF injections

Drug

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

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

    Time frame: 12 months after a patient was included into the study

Secondary outcomes

  1. 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

  2. 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

  3. Identifying NA/NP outcomes (assessed by visual acuity)

    Time frame: Every eye doctors visit between inclusion of patients and their exclusion

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

    Time frame: Measurement during patient interview after about 11 months after inclusion

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 7, 2011
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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