Trial Condition(s):
Macular degeneration
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. (ANDROMEDA)
Bayer Identifier:
19756
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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) - No participation in an investigational program with interventions outside of routine clinical practice - No contra-indications according to the local marketing authorization/ Summary of Product Characteristics (SmPC) - Ability and willingness to participate in telephone interviews
Exclusion Criteria
- Any prior therapy with intravitreal steroids in the study eye. - Concomitant therapy (except nutritional supplements) with any other agent to treat nAMD in the study eye - Any prior transpupillary thermotherapy, photodynamic therapy, macular rotation/ translocation or macular laser in the study eye or - Structural damage to the center of the macula in either eye - Any other condition expected to permanently limit visual acuity outcomes over the course of the study
Trial Summary
Enrollment Goal
554
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Many locations Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Intravitreal aflibercept in neovascular Age-related Macular Degeneration (nAMD): an observational study assessing patient relevant outcomes, real-world treatment pattern and effectiveness
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- Time to first appearance of non-consistenceNon-consistence is: - Failure of subjects to appear to a scheduled injection visit; - Strong time deviation of injections from approved aflibercept posology.Timeframe: Up to 24 months
- Reasons why a patient failed to appear to a scheduled injection visitAsked in telephone interviewsTimeframe: Up to 24 months
Secondary Outcome
- Change in best corrected visual acuity (BCVA) lettersTimeframe: From baseline to 4, 12 and 24 months
- Change in central retinal thickness (CRT)Timeframe: From baseline to 4, 12 and 24 months
- Treatment satisfaction by MAC-TSQTreatment 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).Timeframe: At 4, 12 and 24 months
- Change in treatment satisfactionComprises 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).Timeframe: From 4 month to 12 and 24 months
- Vision-specific quality of life by NEI VFQ-25Vision-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).Timeframe: At baseline, 4, 12 and 24 months
- Change in vision-specific quality of lifeComprises 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).Timeframe: From baseline to 4, 12 and 24 months
- Burden of therapyDescriptive measure summarising information about patient´s time for scheduling and attending appointments and anxiety reasons. Asked in telephone interviews.Timeframe: At 4, 12 and 24 months
- Information about disease and treatmentDescribes to what extent patients were informed about their disease and treatment. Asked in telephone interviews.Timeframe: At 4, 12 and 24 months
- Willingness to continue therapyAsked in telephone interviewsTimeframe: At 4, 12 and 24 months
- Reasons for treatment discontinuationAsked in telephone interviewsTimeframe: At 4, 12 and 24 months
- Change in general quality of life by EQ-5DGeneral 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).Timeframe: From baseline to 12 and 24 months
- Percentage of non-persistent patientsNon-persistence is: Patients terminating treatment with aflibercept.Timeframe: At 12 and 24 months
- Time from baseline to first instance of non-persistenceNon-persistence: Patients terminating treatment with aflibercept.Timeframe: Up to 24 months
- Percentage of patients receiving 3 initial monthly injectionsTimeframe: Up to 24 months
- Percentage of consistently treated patientsNon-consistence is: - Failure of subjects to appear to a scheduled injection visit; - Strong time deviation of injections from approved aflibercept posology.Timeframe: At 12 and 24 months
- Proportion of patients undergoing therapeutic switchTimeframe: At 12 and 24 months
- Reasons for therapeutic switchingAsked in telephone interviewsTimeframe: At 12 and 24 months
- Proportion of patients discontinuing disease monitoring at participating centerTimeframe: At 12 and 24 months
- Average time between visitsTimeframe: Up to 24 months
- Average time between injections in the study eyeTimeframe: Up to 24 months
- Number of injections in the study eye per yearTimeframe: Up to 24 months
- Number of visits per study eye per yearComprises monitoring, injection and post-injection visitsTimeframe: Up to 24 months
- Number of visits in clinics/ ophthalmology practices other than the study center per yearTimeframe: Up to 24 months
- Number of examinations of the study eye per yearComprises optical coherence tomography (OCT), visual acuity tests, funduscopy examinations or angiography examinations.Timeframe: Up to 24 months
- Number of injections until start of observationOnly for pre-treated patientsTimeframe: At baseline
- Duration of treatment until start of observationOnly for pre-treated patientsTimeframe: At baseline
- Type of treatment until start of observationOnly for pre-treated patientsTimeframe: At baseline
Additional Information
Not Available
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