ANDROMEDA: Aflibercept Injection Into the Vitreous Body of the Eye: Study to Learn More About Patient Relevant Outcomes, Real World Treatment Patterns and How Well the Treatment Works for Patients Suffering From Abnormal Growth of New Blood Vessels Under the Retina.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with nAMD_Treatment-naive (anti-VEGF naive) Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months |
Drug: Ivt. Aflibercept (Eylea, BAY86-5321)
Treatment is applied according to routine clinical practice and independent of the study setting.
|
| Patients with nAMD_Pre-treated with IVT-AFL Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months |
Drug: Ivt. Aflibercept (Eylea, BAY86-5321)
Treatment is applied according to routine clinical practice and independent of the study setting.
|
| 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 |
Drug: Ivt. Aflibercept (Eylea, BAY86-5321)
Treatment is applied according to routine clinical practice and independent of the study setting.
|
Outcome Measures
Primary Outcome Measures
- Time to first appearance of non-consistence [Up to 24 months]
Non-consistence is: Failure of subjects to appear to a scheduled injection visit; Strong time deviation of injections from approved aflibercept posology.
- Reasons why a patient failed to appear to a scheduled injection visit [Up to 24 months]
Asked in telephone interviews
Secondary Outcome Measures
- 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]
- Treatment satisfaction by MAC-TSQ [At 4, 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).
- Change in treatment satisfaction [From 4 month to 12 and 24 months]
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).
- Vision-specific quality of life by NEI VFQ-25 [At baseline, 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).
- Change in vision-specific quality of life [From baseline to 4, 12 and 24 months]
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).
- Burden of therapy [At 4, 12 and 24 months]
Descriptive measure summarising information about patient´s time for scheduling and attending appointments and anxiety reasons. Asked in telephone interviews.
- Information about disease and treatment [At 4, 12 and 24 months]
Describes to what extent patients were informed about their disease and treatment. Asked in telephone interviews.
- Willingness to continue therapy [At 4, 12 and 24 months]
Asked in telephone interviews
- Reasons for treatment discontinuation [At 4, 12 and 24 months]
Asked in telephone interviews
- Change in general quality of life by EQ-5D [From baseline to 12 and 24 months]
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).
- Percentage of non-persistent patients [At 12 and 24 months]
Non-persistence is: Patients terminating treatment with aflibercept.
- Time from baseline to first instance of non-persistence [Up to 24 months]
Non-persistence: Patients terminating treatment with aflibercept.
- Percentage of patients receiving 3 initial monthly injections [Up to 24 months]
- Percentage of consistently treated patients [At 12 and 24 months]
Non-consistence is: Failure of subjects to appear to a scheduled injection visit; Strong time deviation of injections from approved aflibercept posology.
- Proportion of patients undergoing therapeutic switch [At 12 and 24 months]
- Reasons for therapeutic switching [At 12 and 24 months]
Asked in telephone interviews
- 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 [Up to 24 months]
Comprises monitoring, injection and post-injection visits
- 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 [Up to 24 months]
Comprises optical coherence tomography (OCT), visual acuity tests, funduscopy examinations or angiography examinations.
- Number of injections until start of observation [At baseline]
Only for pre-treated patients
- Duration of treatment until start of observation [At baseline]
Only for pre-treated patients
- Type of treatment until start of observation [At baseline]
Only for pre-treated patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of neovascular age-related macular degeneration
-
Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice or current treatment with IVT-AFL (all prior anti-VEGF treatments must have been applied by the participating study site)
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No participation in an investigational program with interventions outside of routine clinical practice
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No contra-indications according to the local marketing authorization/ Summary of Product Characteristics (SmPC)
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Ability and willingness to participate in telephone interviews
Exclusion Criteria:
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Any prior therapy with intravitreal steroids in the study eye.
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Concomitant therapy (except nutritional supplements) with any other agent to treat nAMD in the study eye
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Any prior transpupillary thermotherapy, photodynamic therapy, macular rotation/ translocation or macular laser in the study eye or
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Structural damage to the center of the macula in either eye
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Any other condition expected to permanently limit visual acuity outcomes over the course of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Germany |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19756