NCT03278262

Brief Summary

The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting. In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

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

August 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

August 28, 2017

Last Update Submit

October 26, 2018

Conditions

Wet Macular Degeneration

Outcome Measures

Primary Outcomes (3)

  • Change in Visual Acuity (VA) (Snellen)

    Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.

    at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up

  • Change in Early Treatment Diabetic Retinopathy Study (ETDRS)

    Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.

    at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up

  • Change in Lasbarhetsindex (LIX, Readability Index)

    Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden

    at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up

Secondary Outcomes (4)

  • Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points

    At year 1 and year 2

  • Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)

    Up to 2 years

  • Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)

    Up to 2 years

  • Proportion of patients with no need of Vision Aid support

    Up to 2 years

Study Arms (3)

>= 70 letters

Baseline VA \>= 70 letters

Drug: Aflibercept (Eylea, BAY86-5321)

36-69 letters

Baseline VA 36-69 letters

Drug: Aflibercept (Eylea, BAY86-5321)

<=35 letters

Baseline VA \<=35 letters

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321)DRUG

Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.

36-69 letters<=35 letters>= 70 letters

Eligibility Criteria

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

All patients registered in the Swedish Macula Register during the study period.

You may qualify if:

  • Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.

You may not qualify if:

  • Eyes treated previously with another anti-VEGF drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many locations

Lund, Sweden

Location

Related Links

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal 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

August 28, 2017

First Posted

September 11, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

SE(1)