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.

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Ivt. Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT03714308
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2019-01-28
• Primary Completion: 2023-03-06
• Study Completion: 2023-05-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with nAMD_Treatment-naive (anti-VEGF naive)	Ivt. Aflibercept (Eylea, BAY86-5321)	Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
Patients with nAMD_Pre-treated with any anti-VEGF	Ivt. Aflibercept (Eylea, BAY86-5321)	Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
Patients with nAMD_Pre-treated with IVT-AFL	Ivt. Aflibercept (Eylea, BAY86-5321)	Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months

Primary Outcome Measures

Name	Time	Method
Reasons why a patient failed to appear to a scheduled injection visit	Up to 24 months	Asked in telephone interviews
Time to first appearance of non-consistence	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.

Secondary Outcome Measures

Name	Time	Method
Reasons for treatment discontinuation	At 4, 12 and 24 months	Asked in telephone interviews
Number of injections until start of observation	At baseline	Only for pre-treated patients
Time from baseline to first instance of non-persistence	Up to 24 months	Non-persistence: Patients terminating treatment with aflibercept.
Reasons for therapeutic switching	At 12 and 24 months	Asked in telephone interviews
Change in treatment satisfaction	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).
Vision-specific quality of life by NEI VFQ-25	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).
Percentage of consistently treated patients	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.
Change in best corrected visual acuity (BCVA) letters	From baseline to 4, 12 and 24 months
Change in vision-specific quality of life	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).
Information about disease and treatment	At 4, 12 and 24 months	Describes to what extent patients were informed about their disease and treatment. Asked in telephone interviews.
Willingness to continue therapy	At 4, 12 and 24 months	Asked in telephone interviews
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
Type of treatment until start of observation	At baseline	Only for pre-treated patients
Burden of therapy	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.
Change in general quality of life by EQ-5D	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).
Percentage of patients receiving 3 initial monthly injections	Up to 24 months
Proportion of patients undergoing therapeutic switch	At 12 and 24 months
Average time between visits	Up to 24 months
Number of visits in clinics/ ophthalmology practices other than the study center per year	Up to 24 months
Change in central retinal thickness (CRT)	From baseline to 4, 12 and 24 months
Treatment satisfaction by MAC-TSQ	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).
Proportion of patients discontinuing disease monitoring at participating center	At 12 and 24 months
Number of visits per study eye per year	Up to 24 months	Comprises monitoring, injection and post-injection visits
Duration of treatment until start of observation	At baseline	Only for pre-treated patients
Percentage of non-persistent patients	At 12 and 24 months	Non-persistence is: Patients terminating treatment with aflibercept.
Number of examinations of the study eye per year	Up to 24 months	Comprises optical coherence tomography (OCT), visual acuity tests, funduscopy examinations or angiography examinations.

Trial Locations

Locations (1)

Many locations; 🇩🇪 Multiple Locations, Germany