A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment

Inclusion Criteria

• •Part A
• •Panretinal photocoagulation-treated diabetic retinopathy (DR) patients with either no or inactive retinal neovascularization per investigator judgement in the study eye
• •Male or female subjects of age ≥ 18 years
• •Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as any degree of disruption of retinal vascularity in optical coherent tomography angiography (OCTA)
• •Glycosylated Hemoglobin, Type A1C (HbA1c) of ≤ 12.0%
• •Best-corrected visual acuity (VA) ≤75 letters (20/32) in the study eye
• •Best corrected visual acuity (VA) in the non-study eye must be equal to or better than best corrected VA in the study eye. If both eyes are eligible and have identical best corrected VA the investigator may select the study eye.
• •Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two methods of contraception with at least one of them being a highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
• •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• •Part B:
• •Panretinal photocoagulation-treated diabetic retinopathy (DR) patients with either no or inactive retinal neovascularization per investigator judgement
• •Male or female subjects of age ≥ 18 years
• •Presence of significant diabetic macular ischemia (DMI): Large foveal avascular zone (FAZ) defined as those with ≥0.5mm2 area present on optical coherent tomography angiography (OCTA). If FAZ is \<0.5mm2 then an enlarged peri-foveal inter-capillary space in at least 1 quadrant will be sufficient.
• •Glycosylated Hemoglobin, Type A1C (HbA1c) of ≤ 12.0%
• •Best-corrected visual acuity (VA) ≤85 letters (20/20) in the study eye
• •If both eyes are eligible, the investigator may select either eye to be the study eye.
• •Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two methods of contraception with at least one of them being a highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
• •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial