Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients

Completed

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT03382587
• Lead Sponsor: Bayer

Brief Summary

The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.

Detailed Description

Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-05
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• Diagnosis of wet age-related macular degeneration.
• No prior therapy for wet age-related macular degeneration.
• Patients for whom the decision to initiate treatment with IVT-AFL in a T&E regimen was made as per routine clinical practice.
• Patient age >55 years of age

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Exclusion Criteria

• Participation in an investigational program with therapeutical interventions outside of clinical routine practice.
• Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
• Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept (Eylea, BAY86-5321)	Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)	Baseline and at 12 months	mean change in ETDRS letters

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)	Baseline and at 24 months	mean change in ETDRS letters
Mean change in best-corrected visual acuity in relation to the number of injections administered	Baseline and at 12 months; Baseline and at 24 months	Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes
Mean interval between injections	At 12 and 24 months	mean interval displayed in weeks or days
Mean changes from baseline in central retinal thickness (CRT)	Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months	micro meter (µm)
Reasons for termination of therapy (including subsequent therapy at time of discontinuation)	At 12 and 24 months	Categorized into typical reasons for discontinuation such as e.g. death, lost to Follow-up, withdrawal of informed consent, change of treatment regimen, discontinuation of IVT-AFL treatment, interfering surgery or treatment, adverse event, other
Severity of disease reactivation	Baseline and at 12 months; Baseline and at 24 months	Severity of disease reactivation assessed at the investigator's discretion as: no new disease activity / mild / severe
Frequency of disease reactivation	Baseline and at 12 months; Baseline and at 24 months	Disease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator's discretion as: none / new or increasing / decreasing / stable
Reasons for the interval length	At 12 and 24 months	morphology and / or BCVA /other
Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline	Baseline and at 12 months; Baseline and at 24 months	Proportion evaluated as percentage (%) of eyes
Changes from baseline in retinal fluid	Baseline and at 12 months; Baseline and at 24 months	intraretinal or subretinal fluid or pigment epithelial detachment (PED)

Trial Locations

Locations (1)

Many Locations; 🇨🇭 Multiple Locations, Switzerland