A 4 week study with BI 144807 in patients >= 50 years with wet age related macular degeneratio
- Conditions
- patients with newly diagnosed, unilateral, wet Are-Related Macular DegenerationMedDRA version: 16.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-004567-30-AT
- Lead Sponsor
- Boehringer Ingelheim RCV GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
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
Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>;Timepoint(s) of evaluation of this end point: 1: Baseline and 4 weeks<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: Change in neovascular leakage by fluorescein angiography from baseline<br>;Timepoint(s) of evaluation of this end point: 1: Baseline and 4 weeks<br>