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

June 2, 2023 updated by: Bayer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Multiple Locations, Switzerland
        • Many locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
Time Frame: Baseline and at 12 months
mean change in ETDRS letters
Baseline and at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)
Time Frame: Baseline and at 24 months
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
Time Frame: 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
Baseline and at 12 months; Baseline and at 24 months
Mean interval between injections
Time Frame: At 12 and 24 months
mean interval displayed in weeks or days
At 12 and 24 months
Reasons for the interval length
Time Frame: At 12 and 24 months
morphology and / or BCVA /other
At 12 and 24 months
Frequency of disease reactivation
Time Frame: 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
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
Time Frame: Baseline and at 12 months; Baseline and at 24 months
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)
Time Frame: Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
micro meter (µm)
Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
Changes from baseline in retinal fluid
Time Frame: Baseline and at 12 months; Baseline and at 24 months
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)
Time Frame: 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
At 12 and 24 months
Severity of disease reactivation
Time Frame: 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
Baseline and at 12 months; Baseline and at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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