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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT02289924
• Date of registration: 10/11/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy PERSEUS-IT
• Scientific 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
• Date of first enrolment: January 9, 2015
• Target sample size: 912
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02289924
• Study type: Observational

Countries of recruitment

Italy

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Wet Macular Degeneration

Intervention(s)

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Primary Outcome(s)

Mean change of visual acuity from baseline to 12 months. [Time Frame: Baseline to 12 months]

Mean change of visual acuity from baseline to 24 months. [Time Frame: Baseline to 24 months]

Secondary Outcome(s)

Mean change in retinal thickness from baseline [Time Frame: Baseline and at 4,12 and 24 months]

Number of visits outside the study center after 12 and 24 months [Time Frame: At 12 and 24 months]

Number of visual acuity tests [Time Frame: At 12 and 24 months]

Number of combined visits (visits for monitoring and injection) [Time Frame: At 12 and 24 months]

Number of post-injection monitoring visits (visits only for safety checks after injection) [Time Frame: At 12 and 24 months]

Mean time between the first symptoms and diagnosis [Time Frame: Up to 24 months]

Mean time from indication of the Eylea treatment by the treating physician to treatment [Time Frame: Up to 24 months]

Number of clinical visits (visits for injections) [Time Frame: At 12 and 24 months]

Number of monitoring visits (visits only for diagnostic purposes, but without injections) [Time Frame: At 12 and 24 months]

Number of optical coherence tomography (OCT) assessments per patient [Time Frame: At 12 and 24 months]

Mean time between the injections and visits [Time Frame: At 12 and 24 months]

Number of fundoscopy examinations [Time Frame: At 12 and 24 months]

Proportion of patients with no fluid [Time Frame: At 4,12 and 24 months]

Secondary ID(s)

17634

EY1415IT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors