Clinical trial NCT03714308: 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.
Official title: Intravitreal Aflibercept in Neovascular Age-related Macular Degeneration (nAMD): an Observational Study Assessing Patient Relevant Outcomes, Real-world Treatment Pattern and Effectiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Neovascular age-related macular degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with neovascular age-related macular degeneration (nAMD)

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.


Eligibility 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)
* 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

Primary outcomes:
measure: Time to first appearance of non-consistence
timeFrame: Up to 24 months
measure: Reasons why a patient failed to appear to a scheduled injection visit
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA) letters
timeFrame: From baseline to 4, 12 and 24 months
measure: Change in central retinal thickness (CRT)
timeFrame: From baseline to 4, 12 and 24 months
measure: Treatment satisfaction by MAC-TSQ
timeFrame: At 4, 12 and 24 months
measure: Change in treatment satisfaction
timeFrame: From 4 month to 12 and 24 months
measure: Vision-specific quality of life by NEI VFQ-25
timeFrame: At baseline, 4, 12 and 24 months
measure: Change in vision-specific quality of life
timeFrame: From baseline to 4, 12 and 24 months
measure: Burden of therapy
timeFrame: At 4, 12 and 24 months
measure: Information about disease and treatment
timeFrame: At 4, 12 and 24 months
measure: Willingness to continue therapy
timeFrame: At 4, 12 and 24 months
measure: Reasons for treatment discontinuation
timeFrame: At 4, 12 and 24 months
measure: Change in general quality of life by EQ-5D
timeFrame: From baseline to 12 and 24 months
measure: Percentage of non-persistent patients
timeFrame: At 12 and 24 months
measure: Time from baseline to first instance of non-persistence
timeFrame: Up to 24 months
measure: Percentage of patients receiving 3 initial monthly injections
timeFrame: Up to 24 months
measure: Percentage of consistently treated patients
timeFrame: At 12 and 24 months
measure: Proportion of patients undergoing therapeutic switch
timeFrame: At 12 and 24 months
measure: Reasons for therapeutic switching
timeFrame: At 12 and 24 months
measure: Proportion of patients discontinuing disease monitoring at participating center
timeFrame: At 12 and 24 months
measure: Average time between visits
timeFrame: Up to 24 months
measure: Average time between injections in the study eye
timeFrame: Up to 24 months
measure: Number of injections in the study eye per year
timeFrame: Up to 24 months
measure: Number of visits per study eye per year
timeFrame: Up to 24 months
measure: Number of visits in clinics/ ophthalmology practices other than the study center per year
timeFrame: Up to 24 months
measure: Number of examinations of the study eye per year
timeFrame: Up to 24 months
measure: Number of injections until start of observation
timeFrame: At baseline
measure: Duration of treatment until start of observation
timeFrame: At baseline
measure: Type of treatment until start of observation
timeFrame: At baseline
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: