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Completed

NCT Number: 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.

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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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivt. Aflibercept (Eylea, BAY86-5321)

Drug

Treatment is applied according to routine clinical practice and independent of the study setting.

Primary outcomes

  1. Time to first appearance of non-consistence

    Time frame: 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.

  2. Reasons why a patient failed to appear to a scheduled injection visit

    Time frame: Up to 24 months

    Asked in telephone interviews

Secondary outcomes

  1. Change in best corrected visual acuity (BCVA) letters

    Time frame: From baseline to 4, 12 and 24 months

  2. Change in central retinal thickness (CRT)

    Time frame: From baseline to 4, 12 and 24 months

  3. Treatment satisfaction by MAC-TSQ

    Time frame: 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).

  4. Change in treatment satisfaction

    Time frame: 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).

  5. Vision-specific quality of life by NEI VFQ-25

    Time frame: 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).

  6. Change in vision-specific quality of life

    Time frame: 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).

  7. Burden of therapy

    Time frame: 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.

  8. Information about disease and treatment

    Time frame: At 4, 12 and 24 months

    Describes to what extent patients were informed about their disease and treatment. Asked in telephone interviews.

  9. Willingness to continue therapy

    Time frame: At 4, 12 and 24 months

    Asked in telephone interviews

  10. Reasons for treatment discontinuation

    Time frame: At 4, 12 and 24 months

    Asked in telephone interviews

  11. Change in general quality of life by EQ-5D

    Time frame: 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).

  12. Percentage of non-persistent patients

    Time frame: At 12 and 24 months

    Non-persistence is:

    Patients terminating treatment with aflibercept.

  13. Time from baseline to first instance of non-persistence

    Time frame: Up to 24 months

    Non-persistence:

    Patients terminating treatment with aflibercept.

  14. Percentage of patients receiving 3 initial monthly injections

    Time frame: Up to 24 months

  15. Percentage of consistently treated patients

    Time frame: 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.

  16. Proportion of patients undergoing therapeutic switch

    Time frame: At 12 and 24 months

  17. Reasons for therapeutic switching

    Time frame: At 12 and 24 months

    Asked in telephone interviews

  18. Proportion of patients discontinuing disease monitoring at participating center

    Time frame: At 12 and 24 months

  19. Average time between visits

    Time frame: Up to 24 months

  20. Average time between injections in the study eye

    Time frame: Up to 24 months

  21. Number of injections in the study eye per year

    Time frame: Up to 24 months

  22. Number of visits per study eye per year

    Time frame: Up to 24 months

    Comprises monitoring, injection and post-injection visits

  23. Number of visits in clinics/ ophthalmology practices other than the study center per year

    Time frame: Up to 24 months

  24. Number of examinations of the study eye per year

    Time frame: Up to 24 months

    Comprises optical coherence tomography (OCT), visual acuity tests, funduscopy examinations or angiography examinations.

  25. Number of injections until start of observation

    Time frame: At baseline

    Only for pre-treated patients

  26. Duration of treatment until start of observation

    Time frame: At baseline

    Only for pre-treated patients

  27. Type of treatment until start of observation

    Time frame: At baseline

    Only for pre-treated patients

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Intravitreal Aflibercept in Neovascular Age-related Macular Degeneration (nAMD): an Observational Study Assessing Patient Relevant Outcomes, Real-world Treatment Pattern and Effectiveness

Acronym: ANDROMEDA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2018
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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