Phase 2 N=14 Treatment

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

Wet Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02121522 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Jun 2016

Primary outcome: Primary: Change From Baseline in CRT as Measured by SD-OCT on Day 29 — 44.0 μm

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BI 144807 (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Mar 2015

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	—

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.

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

View full record on ClinicalTrials.gov →

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.