Placebo-matching BI 1584862
DrugPlacebo-matching BI 1584862
NCT Number: NCT06769048
This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose.
This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group.
Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.
This study is active but is not currently recruiting participants.
Notify Me50 year and older
All sexes
Interventional
Phase 2
Emanuelli Research & Development Center, Arecibo, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo-matching BI 1584862
BI 1584862
Time frame: Up to week 50.
mm is millimeters.
Time frame: Up to week 50.
EZ stands for ellipsoid zone. OCT stands for optical coherence tomography.
Time frame: Up to week 50.
GA stands for geographic atrophy. OCT stands for optical coherence tomography. mm is millimeters.
Time frame: Up to week 52.
Time frame: Up to week 50.
Time frame: At baseline and at week 50.
Time frame: Up to week 50.
ETDRS is early treatment diabetic retinopathy study.
Time frame: At baseline and at week 50.
ETDRS is early treatment diabetic retinopathy study.
Boehringer Ingelheim
Industry
JADE: Phase II Trial in Patients With Geographic Atrophy: A Randomized, Double-masked, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of BI 1584862
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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