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Completed

NCT Number: NCT03382587

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

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.

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Mean interval between injections

    Time frame: At 12 and 24 months

    mean interval displayed in weeks or days

  4. Reasons for the interval length

    Time frame: At 12 and 24 months

    morphology and / or BCVA /other

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: ASTERIA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2017
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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