A 4 week study with BI 144807 in patients >= 50 years with wet age related macular degeneration

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004567-30-HU

Enrollment

Registered

2014-02-21

Start date

2014-04-15

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with newly diagnosed, unilateral, wet Are-Related Macular Degeneration MedDRA version: 17.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 100000004853

Interventions

Product Name: BI 144807 Product Code: BI 144807 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: BI 144807 Other descriptive name: BI 144807 Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the current study is to investigate the effect of BI 144807 treatment on central 1-mm retinal thickness in wAMD patients as assessed by SD-OCT;Secondary Objective: A secondary outcome will be to assess the effect of BI 144807 on neovascular leakage as assessed by fluorescin angiography;Primary end point(s): 1: Change from baseline in 1mm central retinal thickness as measured by SD-OCT ;Timepoint(s) of evaluation of this end point: 1: Baseline and 4 weeks	—

Measure

Time frame

Main Objective: The primary objective of the current study is to investigate the effect of BI 144807 treatment on central 1-mm retinal thickness in wAMD patients as assessed by SD-OCT;Secondary Objective: A secondary outcome will be to assess the effect of BI 144807 on neovascular leakage as assessed by fluorescin angiography;Primary end point(s): 1: Change from baseline in 1mm central retinal thickness as measured by SD-OCT ;Timepoint(s) of evaluation of this end point: 1: Baseline and 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1: Change in neovascular leakage by fluorescein angiography from baseline ;Timepoint(s) of evaluation of this end point: 1: Baseline and 4 weeks	—

Countries

Austria, Germany, Hungary

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co.KG

clintriage.rdg@boehringer-ingelheim.com0018002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026