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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01448538
First received: October 4, 2011
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Wet Macular Degeneration
Drug: Anti-VEGF injections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Identifying NA/NP outcomes (assessed by visual acuity) [ Time Frame: Every eye doctors visit between inclusion of patients and their exclusion ] [ Designated as safety issue: No ]
  • Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes [ Time Frame: Measurement during patient interview after about 11 months after inclusion ] [ Designated as safety issue: No ]

Enrollment: 486
Study Start Date: August 2011
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Anti-VEGF injections
All Anti-VEGF injections approved for the German market, dosages as defined by doctors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448538

Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01448538     History of Changes
Other Study ID Numbers: 15785, HE-WAMD-01
Study First Received: October 4, 2011
Last Updated: September 15, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Bayer:
Medication Non-Adherence
Medication Persistence
wet macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014