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.

Macular Degeneration Clinical Trial

— ANDROMEDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714308
• Other study ID #: 19756
• Status: Completed
• Start date: January 28, 2019
• Est. completion date: May 12, 2023

Study information

• Verified date: July 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: May 12, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Ivt. Aflibercept (Eylea, BAY86-5321)
Treatment is applied according to routine clinical practice and independent of the study setting.

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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