Wet Age-related Macular DegenerationASTERIANCT03382587
Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 163 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2017to 27 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Aflibercept (Eylea, BAY86-5321)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
mean change in ETDRS letters
Measured: Baseline and at 12 months
Secondary outcomes (10)
Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)
mean change in ETDRS letters
Measured: 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
Measured: Baseline and at 12 months; Baseline and at 24 months
Mean interval between injections
mean interval displayed in weeks or days
Measured: At 12 and 24 months
Reasons for the interval length
morphology and / or BCVA /other
Measured: 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
Measured: 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
Measured: Baseline and at 12 months; Baseline and at 24 months
Mean changes from baseline in central retinal thickness (CRT)
micro meter (µm)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline and at 12 months; Baseline and at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start5 Dec 2017
- Primary completion9 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382587
- Sponsor's protocol ID
- 18574
- Acronym
- ASTERIA
- Status last verified
- Jun 2023
- First submitted
- 11 Dec 2017
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03382587
- Acronym / sponsor ID
- ASTERIA / 18574
- Conditions
- Wet Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | – | Drug: Aflibercept (Eylea, BAY86-5321)Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Aflibercept |
Primary outcome
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
10 secondary outcomes
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 best-corrected visual acuity in relation to the number of injections administered
Time frame: Baseline and at 12 months; Baseline and at 24 months
Mean interval between injections
Time frame: At 12 and 24 months
Reasons for the interval length
Time frame: At 12 and 24 months
Frequency of disease reactivation
Time frame: 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
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
Changes from baseline in retinal fluid
Time frame: 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
Severity of disease reactivation
Time frame: Baseline and at 12 months; Baseline and at 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.