A 4 week study with BI 144807 in patients >= 50 years with wet age related macular degeneratio
- Conditions
- ewly diagnosed unilateral wet age-related macular degeneration (wAMD)MedDRA version: 17.0Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-004567-30-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Men and women with newly diagnosed unilateral active choroidal neovascularization secondary to AMD
2. No prior treatment for neovascular AMD in the study eye and no current or planned concomitant intravitreal anti-vascular endothelial growth factor treatment in the fellow eye
3. Central subfield retinal thickness = 250 µm
4. Presence of sub- and/or intraretinal fluid on SD-OCT
5. Any active CNV with subfoveal leakage
6. Total lesion size not greater than 12 disc areas
7. No subretinal hemorrhage involving the fovea, if the size of hemorrhage is > 50% of the total lesion area
8. No subfoveal fibrosis or atrophy
9. Best-corrected ETDRS visual acuity in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 and 4/63) at screening
10. Patients 50 years of age or older
11. Female subjects must be of non-childbearing potential
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
1. Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
2. The presence of polypoidal choroidal vasculopathy or retinal angiomatous proliferation in the study eye
3. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation
4. Intraocular surgery in the study eye within 3 months prior to screening
5. Aphakia or total absence of the posterior capsule in the study eye
6. Known allergy to fluorescein sodium for injection
7. Current or planned use of medications known to be toxic to the retina, lens or optic nerve
8. Medical history or condition: Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, concomitant use of warfarin or anticoagulation therapy, major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension
9. Planned concomitant use of strong CYP 3A4 or P-gp inhibitors or inducers during the study
10. Planned concomitant use of P-gp substrates, that are narrow therapeutic index drugs
11. Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose or known diseases which could require the use of systemic steroids within the study period
12. Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria. AST or ALT greater than 2.0-fold the upper limit of normal at screening. Patients with total bilirubin TB or INR> 1.5 x upper limit of normal at screening.
13. Patient with impaired renal function defined as calculated GFR< 30 mL/min
14. Significant alcohol or drug abuse within past 2 years
15. Based on central ECG reading, patients with a risk of prolonged QT interval effects
16. Significant disease or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:
• Put the patient at risk because of participation in the study,
• Influence the results of the study,
• Cause concern regarding the patient’s ability to participate in the study.
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 retinal thickness in patients with wAMD as assessed by spectral domain-optical coherence tomography (SD-OCT);Secondary Objective: Secondary objectives are: <br>i) effect of BI 144807 on neovascular leakage as assessed by fluorescein angiography<br>ii) presence of intraretinal fluid, subretinal fluid, and pigmented epithelial detachment <br>iii) changes in visual acuity from baseline <br>iv) safety in patients with wAMD;Primary end point(s): Change from baseline in central retinal thickness as measured by SD-OCT<br>;Timepoint(s) of evaluation of this end point: Baseline and 4 weeks<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change in neovascular leakage by fluorescein angiography from baseline<br>• Visual Acuity determined with letter charts over time, absolute and as change from baseline; <br>• Vascular area determined with cyanine green angiography, absolute and as change from baseline;<br>• Central 1mm retinal thickness over time, absolute and as change from baseline;<br>• Neovascular leakage area as assessed by fluorescein angiography over time, absolute and as change from baseline;<br>• Presence and height of intra-retinal fluid by SD-OCT over time, absolute and as change from baseline;<br>• Presence and height of sub-retinal fluid by SD-OCT over time, absolute and as change from baseline; <br>• Presence and height of pigment epithelial detachment by SD-OCT over time, absolute and as change from baseline;<br>• Safety;Timepoint(s) of evaluation of this end point: Day 1 (Baseline); Day 8 (week 1); Day 15 (week 2); Day 22 (week3); Day 29 (week 4)