check_circleStudy Completed

Choroidal Neovascularization, Macular Degeneration

Bayer Identifier:

18033

ClinicalTrials.gov Identifier:

NCT02821247

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prospective observational study to assess effectiveness of Intravitreal aflibercept in patients with wet macular degeneration in Greece

Trial purpose

This is a prospective, observational, multi-center, study. The study will be conducted in approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120 patients for which the decision to treat with intravitreal aflibercept injections is made at the discretion of the attending physician, according to his/her medical practice. Visits will be performed at baseline, aflibercept first injection (if different from enrollment) and at 12 and 24 months. The 12 and 24 month comprise the data collection visits during which any data generated in the period preceding these visits will be recorded.
All required information for the purposes of this study will be collected using electronic Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be specifically designed for the needs of the study and will adhere to all applicable data protection regulations and requirements with regard to electronic records.
The study observation period for each patient enrolled in this study is the time from the beginning of treatment with intravitreal aflibercept injection up to two years or until discontinuation of intravitreal aflibercept injection-treatment due to any reason including withdrawal of consent or patient loss from follow-up.

Key Participants Requirements

Sex

Both

Age

50 - 100 Years
  • - Treatment naive patients with wet AMD for whom the decision to be treated with intravitreal aflibercept injection in accordance with the Summary of Product Characteristics was made.
    - Patients having signed the informed consent.

  • - Contraindications as listed in the local Summary of Product Characteristics.
    - Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
    - Any prior or concomitant therapy with any other agent (including among others, anti-VEGF agents and photodynamic therapy) to treat wet AMD in the study eye.
    - Patients with previous exposure to systemic anti-VEGF treatment.
    - Patients participating in an investigational program with interventions.
    - Previous macular surgery, including laser, for any retinal pathology in the study eye.

Trial summary

Enrollment Goal
119
Trial Dates
July 2016 - December 2019
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Greece

Primary Outcome

  • Mean change of visual acuity from baseline to 12 months
    date_rangeTime Frame:
    At baseline and 12 months
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    Safety Issue:
    No

Secondary Outcome

  • Change in best corrected visual acuity (BCVA) (with manifest refraction) from baseline at the 24-month timepoint
    date_rangeTime Frame:
    At baseline, At 24 months
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    Safety Issue:
    No
  • Change in visual acuity with glasses from baseline to the 24-month timepoint
    date_rangeTime Frame:
    At baseline, At 24 months
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    Safety Issue:
    No
  • Change in central retinal thickness (OCT measurement) at 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Proportion of patients with no fluid at, 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Total number of routine clinical evaluation (monitoring) visits at 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Number of optical coherence tomography (OCT) assessments per patient
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Number of visual acuity tests
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Number of fundoscopy examinations
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Total number of injection visits at 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
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    Safety Issue:
    No
  • Number of combined visits (monitoring and injection) at 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of fluorescein angiography (FA) tests / patient at 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of indocyanine green angiography (ICGA) tests / patient at 12 and 24 months
    date_rangeTime Frame:
    At 12 months, At 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Prospective obsERvational study to asSEss the effectiveness of Intravitreal aflibercept injection in roUtine clinical practice in treatment naive patientS with wet age-related macular degeneration in Greece
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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