In this clinical study researchers want to gain a deeper understanding of treatment consistence under real world conditions over the course of 24 months of Aflibercept injections into the eye for patients suffering from abnormal growth of new blood vessels under the retina (neovascular age-related macular degeneration). The study aims to identify potential reasons that may allow classification of non-consistence as patient or physician driven. They want to describe treatment effectiveness (how well the treatment works) and associations between treatment effectiveness, non-consistence and patient relevant outcomes, such as vision specific quality of life and treatment satisfaction.
Study Type
OBSERVATIONAL
Enrollment
554
Treatment is applied according to routine clinical practice and independent of the study setting.
Many locations
Multiple Locations, Germany
Time to first appearance of non-consistence
Non-consistence is: * Failure of subjects to appear to a scheduled injection visit; * Strong time deviation of injections from approved aflibercept posology.
Time frame: Up to 24 months
Reasons why a patient failed to appear to a scheduled injection visit
Asked in telephone interviews
Time frame: Up to 24 months
Change in best corrected visual acuity (BCVA) letters
Time frame: From baseline to 4, 12 and 24 months
Change in central retinal thickness (CRT)
Time frame: From baseline to 4, 12 and 24 months
Treatment satisfaction by MAC-TSQ
Treatment satisfaction is assessed with the MAC-TSQ (Macular Disease Treatment Satisfaction Questionnaire) consisting of 14 items (each item is scored from 0-6) resulting in a score range of 0-72 (a higher score represents better treatment satisfaction).
Time frame: At 4, 12 and 24 months
Change in treatment satisfaction
Comprises change in treatment satisfaction from 4 months to 12 and 24 months. Treatment satisfaction is assessed with the MAC-TSQ (Macular Disease Treatment Satisfaction Questionnaire) consisting of 14 items (each item is scored from 0-6) resulting in a score range of 0-72 (a higher score represents better treatment satisfaction).
Time frame: From 4 month to 12 and 24 months
Vision-specific quality of life by NEI VFQ-25
Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
Time frame: At baseline, 4, 12 and 24 months
Change in vision-specific quality of life
Comprises change in vision-specific quality of life between baseline and 4, 12 and 24 months. Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).
Time frame: From baseline to 4, 12 and 24 months
Burden of therapy
Descriptive measure summarising information about patient´s time for scheduling and attending appointments and anxiety reasons. Asked in telephone interviews.
Time frame: At 4, 12 and 24 months
Information about disease and treatment
Describes to what extent patients were informed about their disease and treatment. Asked in telephone interviews.
Time frame: At 4, 12 and 24 months
Willingness to continue therapy
Asked in telephone interviews
Time frame: At 4, 12 and 24 months
Reasons for treatment discontinuation
Asked in telephone interviews
Time frame: At 4, 12 and 24 months
Change in general quality of life by EQ-5D
General quality of life is assessed with EQ-5D ®, a 5-item questionnaire assessing 5 health related dimensions on 5 levels (% is calculated for each level) and complemented by a visual analogue scale (range 0-100, high score represents better quality of life).
Time frame: From baseline to 12 and 24 months
Percentage of non-persistent patients
Non-persistence is: Patients terminating treatment with aflibercept.
Time frame: At 12 and 24 months
Time from baseline to first instance of non-persistence
Non-persistence: Patients terminating treatment with aflibercept.
Time frame: Up to 24 months
Percentage of patients receiving 3 initial monthly injections
Time frame: Up to 24 months
Percentage of consistently treated patients
Non-consistence is: * Failure of subjects to appear to a scheduled injection visit; * Strong time deviation of injections from approved aflibercept posology.
Time frame: At 12 and 24 months
Proportion of patients undergoing therapeutic switch
Time frame: At 12 and 24 months
Reasons for therapeutic switching
Asked in telephone interviews
Time frame: At 12 and 24 months
Proportion of patients discontinuing disease monitoring at participating center
Time frame: At 12 and 24 months
Average time between visits
Time frame: Up to 24 months
Average time between injections in the study eye
Time frame: Up to 24 months
Number of injections in the study eye per year
Time frame: Up to 24 months
Number of visits per study eye per year
Comprises monitoring, injection and post-injection visits
Time frame: Up to 24 months
Number of visits in clinics/ ophthalmology practices other than the study center per year
Time frame: Up to 24 months
Number of examinations of the study eye per year
Comprises optical coherence tomography (OCT), visual acuity tests, funduscopy examinations or angiography examinations.
Time frame: Up to 24 months
Number of injections until start of observation
Only for pre-treated patients
Time frame: At baseline
Duration of treatment until start of observation
Only for pre-treated patients
Time frame: At baseline
Type of treatment until start of observation
Only for pre-treated patients
Time frame: At baseline
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