Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy

Wet Macular Degeneration Clinical Trial

— PERSEUS-IT  

Official title:

PERSEUS-IT. A Prospective Non-intERventional Study to asSEss the Effectiveness of Aflibercept (Eylea®) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289924
• Other study ID #: 17634
• Secondary ID: EY1415IT
• Status: Completed
• Start date: January 9, 2015
• Est. completion date: July 8, 2019

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of "naïve" patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: July 8, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• "Naïve" patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).

Exclusion Criteria:

• Exclusion criteria as listed in the local SPC. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.

• Any concomitant therapy with another agent to treat wet AMD in the study eye.

• Any prior or concomitant therapy with another drug for wAMD.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Nicolo M, Ciucci F, Nardi M, Parolini B, Russo A, Scupola A, Torregrossa S, Vadala M; PERSEUS-IT study investigators. PERSEUS-IT 24-month analysis: a prospective observational study to assess the effectiveness of intravitreal aflibercept in routine clinic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of visual acuity from baseline to 12 months.		Baseline to 12 months
Primary	Mean change of visual acuity from baseline to 24 months.		Baseline to 24 months
Secondary	Number of clinical visits (visits for injections)		At 12 and 24 months
Secondary	Number of monitoring visits (visits only for diagnostic purposes, but without injections)		At 12 and 24 months
Secondary	Number of combined visits (visits for monitoring and injection)		At 12 and 24 months
Secondary	Number of post-injection monitoring visits (visits only for safety checks after injection)		At 12 and 24 months
Secondary	Number of visits outside the study center after 12 and 24 months		At 12 and 24 months
Secondary	Number of optical coherence tomography (OCT) assessments per patient		At 12 and 24 months
Secondary	Number of visual acuity tests		At 12 and 24 months
Secondary	Number of fundoscopy examinations		At 12 and 24 months
Secondary	Mean time between the injections and visits		At 12 and 24 months
Secondary	Mean time between the first symptoms and diagnosis		Up to 24 months
Secondary	Mean time from indication of the Eylea treatment by the treating physician to treatment	Time will be defined as difference in days between clinical indication for the treatment and the first injection	Up to 24 months
Secondary	Proportion of patients with no fluid		At 4,12 and 24 months
Secondary	Mean change in retinal thickness from baseline	As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)	Baseline and at 4,12 and 24 months

External Links

•   Click here to find results for studies related to Bayer products