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Prospective Observational Study to Assess Effectiveness of Intravitreal Aflibercept in Patients With Wet Macular Degeneration in Greece (PERSEUS-GR)

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ClinicalTrials.gov Identifier: NCT02821247
Recruitment Status : Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment
Choroidal Neovascularization Macular Degeneration Drug: VEGF-Trap-Eye (BAY86-5321)

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019


Group/Cohort Intervention/treatment
Group 1
adult wet Age Related Macular degeneration (AMD) treatment naïve and will be treated intravitreal aflibercept injection
Drug: VEGF-Trap-Eye (BAY86-5321)
standard treatment patterns as decided by the physician




Primary Outcome Measures :
  1. Mean change of visual acuity from baseline to 12 months [ Time Frame: baseline and 12 months ]

Secondary Outcome Measures :
  1. Change in best corrected visual acuity (BCVA) (with manifest refraction) from baseline at the 24-month timepoint [ Time Frame: At baseline, At 24 months ]
  2. Change in visual acuity with glasses from baseline to the 24-month timepoint [ Time Frame: At baseline, At 24 months ]
  3. Change in central retinal thickness (OCT measurement) at 12 and 24 months [ Time Frame: At 12 months, At 24 months ]
  4. Proportion of patients with no fluid at, 12 and 24 months [ Time Frame: At 12 months, At 24 months ]
  5. Total number of routine clinical evaluation (monitoring) visits at 12 and 24 months [ Time Frame: At 12 months, At 24 months ]
  6. Number of optical coherence tomography (OCT) assessments per patient [ Time Frame: At 12 months, At 24 months ]
  7. Number of visual acuity tests [ Time Frame: At 12 months, At 24 months ]
  8. Number of fundoscopy examinations [ Time Frame: At 12 months, At 24 months ]
  9. Total number of injection visits at 12 and 24 months [ Time Frame: At 12 months, At 24 months ]
  10. Number of combined visits (monitoring and injection) at 12 and 24 months [ Time Frame: At 12 months, At 24 months ]
  11. Number of fluorescein angiography (FA) tests / patient at 12 and 24 months [ Time Frame: At 12 months, At 24 months ]
  12. Number of indocyanine green angiography (ICGA) tests / patient at 12 and 24 months [ Time Frame: At 12 months, At 24 months ]


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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of patients treated with Aphlibercept as first treatment for wAMD. ( Treatment Naïve Patients)
Criteria

Inclusion Criteria:

  • 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 is made. - Patients having signed the informed consent

Exclusion Criteria:

  • 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.

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): NCT02821247


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02821247     History of Changes
Other Study ID Numbers: 18033
SIRIUS/OS-CY-1668 ( Other Identifier: company internal )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bayer:
Treatment Naïve Patients

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases