- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01448538
Non-Persistence/Non-Adherence (NP/NA) in Wet Age-related Macular Degeneration (wAMD) Patients in Germany
Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Many Locations, Germany
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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All Anti-VEGF injections approved for the German market, dosages as defined by doctors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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12 months after a patient was included into the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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12 months after inclusion of patients
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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
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Measurement during patient interviews about 4/8 months after inclusion
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Identifying NA/NP outcomes (assessed by visual acuity)
Time Frame: Every eye doctors visit between inclusion of patients and their exclusion
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Every eye doctors visit between inclusion of patients and their exclusion
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Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes
Time Frame: Measurement during patient interview after about 11 months after inclusion
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Measurement during patient interview after about 11 months after inclusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15785
- HE-WAMD-01 (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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