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Trial record 2 of 6 for:    Asteria

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 : Recruiting
First Posted : December 26, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment
Wet Age-related Macular Degeneration 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
Estimated Enrollment : 160 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
Estimated Primary Completion Date : November 12, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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

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

Information from the National Library of Medicine

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


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
Switzerland
Many Locations Recruiting
Multiple Locations, Switzerland
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03382587     History of Changes
Other Study ID Numbers: 18574
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases