NCT03521895

Brief Summary

The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS. The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 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

April 30, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

April 30, 2018

Last Update Submit

January 8, 2020

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline

    At baseline and 12 months

Secondary Outcomes (5)

  • Mean time from diagnosis by the treating physician to start of treatment

    At baseline

  • Proportion of patients gaining 5, 10 or 15 or more letters

    At 12 months

  • Proportion of patients with ≥70 letters VA

    At 12 months

  • Proportion of patients with ≥73 letters VA

    At 12 months

  • Proportion of patients losing 5, 10 or 15 or more letters

    At 12 months

Study Arms (1)

Treatment naïve wAMD

Treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW

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

Interventions

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

Patients observed with regular and irregular treatment course

Treatment naïve wAMD

Eligibility Criteria

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

This integrated analysis will include only treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW.

You may qualify if:

  • PERSEUS
  • Patients with wet AMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC)
  • Documentation of at least one Aflibercept (Eylea) injection
  • Assessment of at least one visual acuity measurement with available VA letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available VA letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection RAINBOW
  • Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
  • Patient who meet the local indication criteria for Eylea treatment
  • At least one BCVA after the 1st Eylea injection
  • BCVA at baseline
  • Patient with no history of retinal disease
  • Patient not previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye (for fellow eye allowed).
  • For patients with both eyes treated, the eye firstly treated at initial visit will be considered as study eye. If both eyes are treated during initial visit, the treated eye with worst Best-Corrected Visual Acuity (BCVA) at M0 will be retained. If the two conditions are similar the study eye is the Right eye by convention

You may not qualify if:

  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
  • All patients previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye will additionally be excluded for this integrated analysis
  • Any concomitant therapy with another agent to treat wet AMD in the study eye RAINBOW
  • Patient who does not meet the local indication criteria for Eylea treatment. Contraindications listed in the SmPCs must be taken into account
  • Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
  • Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
  • Patient taking part in an interventional study at the time of enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many locations

Multiple Locations, Germany

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

May 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

DE(1)