A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration

The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1313.20.43001 Boehringer Ingelheim Investigational Site, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration

Exclusion criteria

Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma

Treatment and study plan

BI 144807

Drug

twice daily

Primary outcomes

Change From Baseline in CRT as Measured by SD-OCT on Day 29

Time frame: Baseline (day 1) and day 29

Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.

Secondary outcomes

Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29

Time frame: Baseline and day 29

Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Single Arm Open Label Study to Evaluate the Pharmacodynamics and Safety of a 4 wk Treatment With BI 144807 in Patients With Newly Diagnosed Wet Age Related Macular Degeneration (wAMD)

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 23, 2014
Registry last updated: Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed