The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting (INSIGHT)

Bayer

Status: Completed

Conditions: Wet Macular Degeneration

Treatments: Drug: Aflibercept (Eylea, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT03278262

19473

Details and patient eligibility

About

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.

Enrollment: 2,312 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Eyes treated previously with another anti-VEGF drug.

Trial design

2,312 participants in 3 patient groups

>= 70 letters

Description:

Baseline VA \>= 70 letters

Treatment:

Drug: Aflibercept (Eylea, BAY86-5321)

36-69 letters

Description:

Baseline VA 36-69 letters

Treatment:

Drug: Aflibercept (Eylea, BAY86-5321)

<=35 letters

Description:

Baseline VA \<=35 letters

Treatment:

Drug: Aflibercept (Eylea, BAY86-5321)