This is a study in people with an eye disease called wet age-related macular degeneration (wAMD). The purpose of the study is to find out how well different doses of a medicine called BI 836880 are tolerated. People can participate if they are at least 55 years old and if they have new blood vessels in their eyes despite treatment (anti-VEGF therapies). The study has 2 parts. In the first part, people get only 1 dose of BI 836880. This part takes 6 weeks. In the second part, people get 3 times the same dose of BI 836880. This part takes 6 months. BI 836880 is injected into the eye. During the entire study doctors regularly check the health of the participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Solution for Intravitreal (IVT) injection
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
Verum Research, LLC
Eugene, Oregon, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
...and 4 more locations
SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)
Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).
Time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
MRD-part: Number of Participants With Drug Related Adverse Events (AEs)
Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs)
Time frame: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.
SRD-part: Number of Participants With Drug Related Adverse Events (AEs)
Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs).
Time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye.
Time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12
Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12.
Time frame: At baseline and at week 12.
MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12
Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment.
Time frame: At baseline and at Week 12.
MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit
Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator: * Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR * Decrease in BCVA of \>5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR * Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored.
Time frame: From last drug administration at Week 8 until End of Trial, up to 16 weeks.
MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye.
Time frame: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.
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