check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

19756

ClinicalTrials.gov Identifier:

NCT03714308

EudraCT Number:

Not Available

EU CT Number:

Not Available
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.

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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
January 2019 - May 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 24 months
  • Reasons why a patient failed to appear to a scheduled injection visit
    Asked in telephone interviews
    date_rangeTime Frame:
    Up to 24 months

Secondary Outcome

  • Change in best corrected visual acuity (BCVA) letters
    date_rangeTime Frame:
    From baseline to 4, 12 and 24 months
  • Change in central retinal thickness (CRT)
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime Frame:
    At 4, 12 and 24 months
  • Willingness to continue therapy
    Asked in telephone interviews
    date_rangeTime Frame:
    At 4, 12 and 24 months
  • Reasons for treatment discontinuation
    Asked in telephone interviews
    date_rangeTime 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).
    date_rangeTime Frame:
    From baseline to 12 and 24 months
  • Percentage of non-persistent patients
    Non-persistence is: Patients terminating treatment with aflibercept.
    date_rangeTime Frame:
    At 12 and 24 months
  • Time from baseline to first instance of non-persistence
    Non-persistence: Patients terminating treatment with aflibercept.
    date_rangeTime Frame:
    Up to 24 months
  • Percentage of patients receiving 3 initial monthly injections
    date_rangeTime 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.
    date_rangeTime Frame:
    At 12 and 24 months
  • Proportion of patients undergoing therapeutic switch
    date_rangeTime Frame:
    At 12 and 24 months
  • Reasons for therapeutic switching
    Asked in telephone interviews
    date_rangeTime Frame:
    At 12 and 24 months
  • Proportion of patients discontinuing disease monitoring at participating center
    date_rangeTime Frame:
    At 12 and 24 months
  • Average time between visits
    date_rangeTime Frame:
    Up to 24 months
  • Average time between injections in the study eye
    date_rangeTime Frame:
    Up to 24 months
  • Number of injections in the study eye per year
    date_rangeTime Frame:
    Up to 24 months
  • Number of visits per study eye per year
    Comprises monitoring, injection and post-injection visits
    date_rangeTime Frame:
    Up to 24 months
  • Number of visits in clinics/ ophthalmology practices other than the study center per year
    date_rangeTime 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.
    date_rangeTime Frame:
    Up to 24 months
  • Number of injections until start of observation
    Only for pre-treated patients
    date_rangeTime Frame:
    At baseline
  • Duration of treatment until start of observation
    Only for pre-treated patients
    date_rangeTime Frame:
    At baseline
  • Type of treatment until start of observation
    Only for pre-treated patients
    date_rangeTime Frame:
    At baseline

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
N/A