NCT02289924

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
912

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2019

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4.2 years

First QC Date

November 10, 2014

Last Update Submit

November 3, 2023

Conditions

Wet Macular Degeneration

Keywords

wet AMD

Outcome Measures

Primary Outcomes (2)

  • Mean change of visual acuity from baseline to 12 months.

    Baseline to 12 months

  • Mean change of visual acuity from baseline to 24 months.

    Baseline to 24 months

Secondary Outcomes (13)

  • Number of clinical visits (visits for injections)

    At 12 and 24 months

  • Number of monitoring visits (visits only for diagnostic purposes, but without injections)

    At 12 and 24 months

  • Number of combined visits (visits for monitoring and injection)

    At 12 and 24 months

  • Number of post-injection monitoring visits (visits only for safety checks after injection)

    At 12 and 24 months

  • Number of visits outside the study center after 12 and 24 months

    At 12 and 24 months

  • +8 more secondary outcomes

Study Arms (1)

Cohort 1

According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy

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

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)DRUG

Administration by intravitreal injection

Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

wet AMD (wet age-related macular degeneration) patients

You may qualify if:

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

You may not qualify if:

  • Any concomitant therapy with another agent to treat wet AMD in the study eye.
  • Any prior or concomitant therapy with another drug for wAMD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Italy

Location

Related 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 clinical practice in Italy in patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3185-3195. doi: 10.1007/s00417-022-05679-6. Epub 2022 May 5.

    PMID: 35511286RESULT

Related Links

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 13, 2014

Study Start

January 9, 2015

Primary Completion

March 28, 2019

Study Completion

July 8, 2019

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

IT(1)