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

An Observational Study to Assess the Use of Intravitreal Aflibercept Injections in a Routine "Treat and Extend" Regimen in Treatment-naïve Patients Diagnosed With Wet Age-related Macular Degeneration

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.

Study Overview

• Status: Completed
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept (Eylea, BAY86-5321)

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.

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• Switzerland
  • Multiple Locations, Switzerland
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aflibercept; Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme	Drug: Aflibercept (Eylea, BAY86-5321); Intravitreal aflibercept injections used in a routine "treat and extend" regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)	mean change in ETDRS letters	Baseline and at 24 months
Mean change in best-corrected visual acuity in relation to the number of injections administered	Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes	Baseline and at 12 months; Baseline and at 24 months
Mean interval between injections	mean interval displayed in weeks or days	At 12 and 24 months
Reasons for the interval length	morphology and / or BCVA /other	At 12 and 24 months
Frequency of disease reactivation	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	Baseline and at 12 months; Baseline and at 24 months
Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline	Proportion evaluated as percentage (%) of eyes	Baseline and at 12 months; Baseline and at 24 months
Mean changes from baseline in central retinal thickness (CRT)	micro meter (µm)	Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
Changes from baseline in retinal fluid	intraretinal or subretinal fluid or pigment epithelial detachment (PED)	Baseline and at 12 months; Baseline and at 24 months
Reasons for termination of therapy (including subsequent therapy at time of discontinuation)	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	At 12 and 24 months
Severity of disease reactivation	Severity of disease reactivation assessed at the investigator's discretion as: no new disease activity / mild / severe	Baseline and at 12 months; Baseline and at 24 months

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer Healthcare products.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• 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: 18574

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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