check_circleStudy Completed

Wet Macular Degeneration

Bayer Identifier:

15785

ClinicalTrials.gov Identifier:

NCT01448538

EudraCT Number:

Not Available

EU CT Number:

Not Available
Non-Persistence/Non-Adherence (NP/NA) in wet age-related macular degeneration (wAMD) patients in Germany

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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).
  • - 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.

Trial summary

Enrollment Goal
480
Trial Dates
August 2011 - February 2014
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    12 months after a patient was included into the study
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    12 months after inclusion of patients
    enhanced_encryption
    Safety Issue:
    No
  • Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)
    date_rangeTime Frame:
    Measurement during patient interviews about 4/8 months after inclusion
    enhanced_encryption
    Safety Issue:
    No
  • Identifying NA/NP outcomes (assessed by visual acuity)
    date_rangeTime Frame:
    Every eye doctors visit between inclusion of patients and their exclusion
    enhanced_encryption
    Safety Issue:
    No
  • Identifying patients’ preferences (based on patients' questionnaires) towards treatment and treatment schemes
    date_rangeTime Frame:
    Measurement during patient interview after about 11 months after inclusion
    enhanced_encryption
    Safety Issue:
    No

Trial design

Non-Persistence/Non-Adherence of German wAMD patients related to their anti-VEGF injections: extent, explanations and patients’ preferences
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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