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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with nAMD_Treatment-naive (anti-VEGF naive) | Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months |
| |
| Patients with nAMD_Pre-treated with IVT-AFL | Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months |
| |
| Patients with nAMD_Pre-treated with any anti-VEGF | Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivt. Aflibercept (Eylea, BAY86-5321) | Drug | Treatment is applied according to routine clinical practice and independent of the study setting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first appearance of non-consistence | Non-consistence is:
| Up to 24 months |
| Reasons why a patient failed to appear to a scheduled injection visit | Asked in telephone interviews | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best corrected visual acuity (BCVA) letters | From baseline to 4, 12 and 24 months | |
| Change in central retinal thickness (CRT) | From baseline to 4, 12 and 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with neovascular age-related macular degeneration (nAMD)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Germany |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| 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). |
| 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). | 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). | 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). | 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. | 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. | At 4, 12 and 24 months |
| Willingness to continue therapy | Asked in telephone interviews | At 4, 12 and 24 months |
| Reasons for treatment discontinuation | Asked in telephone interviews | 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). | From baseline to 12 and 24 months |
| Percentage of non-persistent patients | Non-persistence is: Patients terminating treatment with aflibercept. | At 12 and 24 months |
| Time from baseline to first instance of non-persistence | Non-persistence: Patients terminating treatment with aflibercept. | Up to 24 months |
| Percentage of patients receiving 3 initial monthly injections | Up to 24 months |
| Percentage of consistently treated patients | Non-consistence is:
| At 12 and 24 months |
| Proportion of patients undergoing therapeutic switch | At 12 and 24 months |
| Reasons for therapeutic switching | Asked in telephone interviews | At 12 and 24 months |
| Proportion of patients discontinuing disease monitoring at participating center | At 12 and 24 months |
| Average time between visits | Up to 24 months |
| Average time between injections in the study eye | Up to 24 months |
| Number of injections in the study eye per year | Up to 24 months |
| Number of visits per study eye per year | Comprises monitoring, injection and post-injection visits | Up to 24 months |
| Number of visits in clinics/ ophthalmology practices other than the study center per year | 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. | Up to 24 months |
| Number of injections until start of observation | Only for pre-treated patients | At baseline |
| Duration of treatment until start of observation | Only for pre-treated patients | At baseline |
| Type of treatment until start of observation | Only for pre-treated patients | At baseline |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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