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)

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Ivt. Aflibercept (Eylea, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 554

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with neovascular age-related macular degeneration (nAMD)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with nAMD_Treatment-naive (anti-VEGF naive); Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months	Drug: Ivt. Aflibercept (Eylea, BAY86-5321); Treatment is applied according to routine clinical practice and independent of the study setting.
Patients with nAMD_Pre-treated with IVT-AFL; Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months	Drug: Ivt. Aflibercept (Eylea, BAY86-5321); Treatment is applied according to routine clinical practice and independent of the study setting.
Patients with nAMD_Pre-treated with any anti-VEGF; Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months	Drug: Ivt. Aflibercept (Eylea, BAY86-5321); Treatment is applied according to routine clinical practice and independent of the study setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months
Reasons why a patient failed to appear to a scheduled injection visit	Asked in telephone interviews	Up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Neovascular age-related macular degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 19756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No