This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans. This study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections. Participants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
BI 3812465
BI 3812465
BI 3812465
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Network Arizona
Scottsdale, Arizona, United States
RECRUITINGWin Retina
Arcadia, California, United States
RECRUITINGRetina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS)
Time frame: Up to 169 days.
Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS
Time frame: Up to 169 days.
Occurrence of AEs from first IMP administration until EOS
Time frame: Up to 169 days.
Occurrence of serious adverse events (SAEs) from first IMP administration until EOS
Time frame: Up to 169 days.
Part 1: Occurrence of ocular AEs in the study eye from first IMP administration until EOS
Time frame: Up to 169 days.
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Global Research Management
Glendale, California, United States
RECRUITINGRetina Associates of Southern California
Huntington Beach, California, United States
NOT_YET_RECRUITINGCalifornia Retina Consultants-Oxnard-70187
Oxnard, California, United States
RECRUITINGRetinal Consultants Medical Group
Sacramento, California, United States
RECRUITINGBay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
RECRUITINGRetina Group of New England, PC
Waterford, Connecticut, United States
RECRUITING...and 19 more locations