Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients (ASTERIA)
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ClinicalTrials.gov Identifier: NCT03382587 |
Recruitment Status :
Completed
First Posted : December 26, 2017
Last Update Posted : August 26, 2019
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Condition or disease | Intervention/treatment |
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Wet Age-related Macular Degeneration | Drug: Aflibercept (Eylea, BAY86-5321) |
Study Type : | Observational |
Actual Enrollment : | 163 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
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 |
Actual Study Start Date : | December 5, 2017 |
Actual Primary Completion Date : | November 9, 2018 |
Actual Study Completion Date : | November 27, 2018 |

Group/Cohort | Intervention/treatment |
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Aflibercept
Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
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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 |
- 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
- 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
- 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
- Mean interval between injections [ Time Frame: At 12 and 24 months ]mean interval displayed in weeks or days
- Reasons for the interval length [ Time Frame: At 12 and 24 months ]morphology and / or BCVA /other
- 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
- 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
- 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)
- 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)
- 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
- 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

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382587
Switzerland | |
Many Locations | |
Multiple Locations, Switzerland |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT03382587 |
Other Study ID Numbers: |
18574 |
First Posted: | December 26, 2017 Key Record Dates |
Last Update Posted: | August 26, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Aflibercept Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |