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

Boehringer Ingelheim14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wet Macular Degeneration

Interventions

BI 144807DRUG

twice daily

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

1313.20.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

1313.20.49004 Boehringer Ingelheim Investigational Site

Bonn, Germany

1313.20.49002 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Outcomes

Primary Outcomes

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

Time frame: Baseline (day 1) and day 29

Secondary Outcomes

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

Time frame: Baseline and day 29

Data from ClinicalTrials.gov

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