AzTrials
AzTrials

Macular DegenerationANDROMEDANCT03714308

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.

An observational study of Macular Degeneration, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Ivt. Aflibercept (Eylea, BAY86-5321)
How many people
554 participants
Where
1 siteGermany
Study dates
28 Jan 2019to 12 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with neovascular age-related macular degeneration (nAMD)

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Many locations

    Multiple Locations

Other trials in Germany

About this study

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

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.

Being tested
Ivt. Aflibercept (Eylea, BAY86-5321)
Keywords
Neovascular age-related macular degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivt. Aflibercept (Eylea, BAY86-5321)Drug

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

Study groups in NCT03714308
Study groupRoleWhat they receive
Patients with nAMD_Treatment-naive (anti-VEGF naive)Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
Receives: Drug: Ivt. Aflibercept (Eylea, BAY86-5321)
Patients with nAMD_Pre-treated with IVT-AFLObservational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
Receives: Drug: Ivt. Aflibercept (Eylea, BAY86-5321)
Patients with nAMD_Pre-treated with any anti-VEGFObservational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
Receives: Drug: Ivt. Aflibercept (Eylea, BAY86-5321)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

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

    Asked in telephone interviews

    Measured: Up to 24 months

Secondary outcomes (27)

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

    Measured: From baseline to 4, 12 and 24 months

  2. Change in central retinal thickness (CRT)

    Measured: From baseline to 4, 12 and 24 months

  3. 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).

    Measured: At 4, 12 and 24 months

  4. 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).

    Measured: From 4 month to 12 and 24 months

  5. 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).

    Measured: At baseline, 4, 12 and 24 months

  6. 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).

    Measured: From baseline to 4, 12 and 24 months

  7. Burden of therapy

    Descriptive measure summarising information about patient´s time for scheduling and attending appointments and anxiety reasons. Asked in telephone interviews.

    Measured: At 4, 12 and 24 months

  8. Information about disease and treatment

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

    Measured: At 4, 12 and 24 months

  9. Willingness to continue therapy

    Asked in telephone interviews

    Measured: At 4, 12 and 24 months

  10. Reasons for treatment discontinuation

    Asked in telephone interviews

    Measured: At 4, 12 and 24 months

  11. 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).

    Measured: From baseline to 12 and 24 months

  12. Percentage of non-persistent patients

    Non-persistence is:

    Patients terminating treatment with aflibercept.

    Measured: At 12 and 24 months

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

    Non-persistence:

    Patients terminating treatment with aflibercept.

    Measured: Up to 24 months

  14. Percentage of patients receiving 3 initial monthly injections

    Measured: Up to 24 months

  15. 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.

    Measured: At 12 and 24 months

  16. Proportion of patients undergoing therapeutic switch

    Measured: At 12 and 24 months

  17. Reasons for therapeutic switching

    Asked in telephone interviews

    Measured: At 12 and 24 months

  18. Proportion of patients discontinuing disease monitoring at participating center

    Measured: At 12 and 24 months

  19. Average time between visits

    Measured: Up to 24 months

  20. Average time between injections in the study eye

    Measured: Up to 24 months

  21. Number of injections in the study eye per year

    Measured: Up to 24 months

  22. Number of visits per study eye per year

    Comprises monitoring, injection and post-injection visits

    Measured: Up to 24 months

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

    Measured: Up to 24 months

  24. Number of examinations of the study eye per year

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

    Measured: Up to 24 months

  25. Number of injections until start of observation

    Only for pre-treated patients

    Measured: At baseline

  26. Duration of treatment until start of observation

    Only for pre-treated patients

    Measured: At baseline

  27. Type of treatment until start of observation

    Only for pre-treated patients

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start28 Jan 2019
  3. Primary completion6 Mar 2023
  4. Study completion12 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03714308
Sponsor's protocol ID
19756
Acronym
ANDROMEDA
Status last verified
Jul 2023
First submitted
25 Sep 2018
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Degeneration, run by Bayer at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first appearance of non-consistence (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03714308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in