Phase 2
Completed N=14
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration
Wet Macular Degeneration
Source: ClinicalTrials.gov NCT02121522 ↗
Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Jun 2016
Primary outcomePrimary: Change From Baseline in CRT as Measured by SD-OCT on Day 29 — 44.0 μm
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in CRT as Measured by SD-OCT on Day 29 |
44.0 | — |
| SECONDARY Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29 |
-0.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02121522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.