Trial Outcomes & Findings for A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy (NCT NCT04002310)

Last Updated: 2023-09-15

Results Overview

SRD part: Number of patients with ocular or systemic DLEs from drug administration. Systemic DLEs were defined as drug-related adverse events (AEs), as defined by the investigator, of moderate or severe intensity on the Common terminology criteria for adverse events (CTCAE) scale, and included diarrhea, cough, or patient-reported paraesthesia, dysgeusia, taste abnormality, taste disorder, or hyposmia. Single rising dose (SRD) part.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

From drug administration until end of trial, up to 100 days.

Results posted on

2023-09-15

Participant Flow

Open label, non-randomized, uncontrolled trial to test how single rising intravitreal doses and multiple doses of BI 754132 are tolerated in patients with geographic atrophy. Recruitment was to be done successively for the dose groups. The multiple dose (MD) part recruited patients only after the single rising dose (SRD) part was completed and safety of the selected dose was endorsed by the safety monitoring committee.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	0.3 mg BI 754132 - SRD Part 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - MD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose (MD) part.
Overall Study STARTED	3	3	3	6	3
Overall Study Treated	3	3	3	6	3
Overall Study COMPLETED	3	3	3	6	2
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	0.3 mg BI 754132 - SRD Part 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - MD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose (MD) part.
Overall Study Sponsor put on hold on treatment plan.	0	0	0	0	1

Baseline Characteristics

A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=6 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - MD Part n=3 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose (MD) part.	Total n=18 Participants Total of all reporting groups
Age, Continuous	78.3 Years STANDARD_DEVIATION 4.9 • n=93 Participants	78.7 Years STANDARD_DEVIATION 2.5 • n=4 Participants	70.7 Years STANDARD_DEVIATION 8.1 • n=27 Participants	77.7 Years STANDARD_DEVIATION 6.0 • n=483 Participants	77.3 Years STANDARD_DEVIATION 8.3 • n=36 Participants	76.7 Years STANDARD_DEVIATION 6.2 • n=10 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants	2 Participants n=36 Participants	12 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	6 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	3 Participants n=36 Participants	18 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	3 Participants n=36 Participants	18 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: From drug administration until end of trial, up to 100 days.

Population: Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132. Only participants included in the SRD part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=6 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From drug administration until end of trial, up to 155 days

Population: Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132. Only participants included in the MD part.

Number of patients with drug-related adverse events (AEs). Multiple dose (MD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
MD Part: Number of Patients With Drug Related Adverse Events (AEs)	2 Participants	—	—	—

SECONDARY outcome

Timeframe: From drug administration until end of trial, up to 100 days.

Population: Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132. Only participants included in the SRD part.

Number of patients with drug-related AEs. Single rising dose (SRD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=6 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
SRD Part: Number of Patients With Drug-related Adverse Events (AEs)	1 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From drug administration until end of trial, up to 100 days.

Population: Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132. Only participants included in the SRD part.

Number of patients with any ocular adverse events in the study eye. Single rising dose (SRD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=6 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye	1 Participants	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all patients in the treated set (TS) who provided at least 1 plasma sample for determination of PK parameters and whose data were not excluded due to a protocol violation relevant to the evaluation of the PK or due to PK non-evaluability. Only SRD part. For the 6 mg arm: Only patients with measurable serum concentration of BI (2 out of 6) are reported.

Maximum serum concentration of BI 754132 after a single intravitreal dose (Cmax). Single rising dose (SRD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=2 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax)	NA nanogram/milliliter (ng/mL) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	NA nanogram/milliliter (ng/mL) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	NA nanogram/milliliter (ng/mL) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	26.9 nanogram/milliliter (ng/mL) Standard Deviation 2.55

SECONDARY outcome

Timeframe: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.

Area under the concentration-time curve of BI 754132 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞). Singe rising dose (SRD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=2 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	NA Hoursnanogram per milliliter (hng/mL) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	NA Hoursnanogram per milliliter (hng/mL) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	NA Hoursnanogram per milliliter (hng/mL) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	4620 Hoursnanogram per milliliter (hng/mL) Standard Deviation 2220

SECONDARY outcome

Timeframe: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.

Time from dosing to maximum serum concentration of BI 754132 (tmax). Single rising dose (SRD part).

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 Participants 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 Participants 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=2 Participants 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax)	NA Hours (h) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	NA Hours (h) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	NA Hours (h) Standard Deviation NA Results could not be calculated, as none of the patients had sufficient measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	72.5 Hours (h) Standard Deviation 96.9

SECONDARY outcome

Timeframe: Up to 29 days.

Systematic exposure of BI 754132 after multiple intravitreal doses as assessed by Cmin,1 (trough levels of BI 754132 before second administration). Multiple dose (MD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1)	NA Nanogram/milliliter (ng/mL) Standard Deviation NA Not calculable, as none of the patients had any measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	—	—	—

SECONDARY outcome

Timeframe: Up to 57 days.

Systematic exposure of BI 754132 after multiple intravitreal doses as assessed by Cmin,2 (trough levels of BI 754132 before third administration). Multiple dose (MD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2)	NA Nanogram/milliliter (ng/mL) Standard Deviation NA Not calculable, as none of the patients had any measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	—	—	—

SECONDARY outcome

Timeframe: At Day 85, 113 and Day 155.

Plasma concentration of BI 754132 4, 8 and 14 weeks after the third administration. Multiple dose (MD) part.

Outcome measures

Outcome measures
Measure	0.3 mg BI 754132 - SRD Part n=3 Participants 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration 4 weeks after the third administration	NA Nanogram/milliliter (ng/mL) Not calculable, as none of the patients had any measurable (i.e. above lower limit of quantification (LLOQ)) serum concentration of BI 754132.	—	—	—
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration 8 weeks after the third administration	NA Nanogram/milliliter (ng/mL) Not calculable, as none of the patients had any measurable (i.e. above LLOQ) serum concentration of BI 754132.	—	—	—
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration 14 weeks after the third administration	NA Nanogram/milliliter (ng/mL) Not calculable, as none of the patients had any measurable (i.e. above LLOQ) serum concentration of BI 754132.	—	—	—

Adverse Events

0.3 mg BI 754132 - SRD Part

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

1 mg BI 754132 - SRD Part

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

3 mg BI 754132 - SRD Part

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

6 mg BI 754132 - SRD Part

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

6 mg BI 754132 - MD Part

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.3 mg BI 754132 - SRD Part n=3 participants at risk 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 participants at risk 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 participants at risk 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=6 participants at risk 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - MD Part n=3 participants at risk 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose (MD) part.
Eye disorders Eye haemorrhage	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Optic ischaemic neuropathy	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Papilloedema	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.

Other adverse events

Other adverse events
Measure	0.3 mg BI 754132 - SRD Part n=3 participants at risk 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part.	1 mg BI 754132 - SRD Part n=3 participants at risk 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	3 mg BI 754132 - SRD Part n=3 participants at risk 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - SRD Part n=6 participants at risk 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part.	6 mg BI 754132 - MD Part n=3 participants at risk 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose (MD) part.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Dry eye	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Eye pruritus	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Lacrimation increased	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Photophobia	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Photopsia	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Retinal haemorrhage	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Visual impairment	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Vitreous floaters	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Eye disorders Vitreous opacities	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Gastrointestinal disorders Abdominal pain lower	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Gastrointestinal disorders Constipation	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Gastrointestinal disorders Flatulence	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Gastrointestinal disorders Nausea	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
General disorders Asthenia	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
General disorders Pain	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Infections and infestations Cystitis	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Injury, poisoning and procedural complications Ocular procedural complication	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	16.7% 1/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Investigations C-reactive protein increased	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Investigations Glomerular filtration rate decreased	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Nervous system disorders Headache	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Vascular disorders Hypertension	33.3% 1/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/6 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.	0.00% 0/3 • From first drug administration until end of trial, up to 100 days for single rising dose (SRD) part and up to 155 days for multiple dose (MD) part. For BI 754132, the residual effect period (REP) after Intravitreal (IVT) administration is not known. Therefore, all adverse events with an onset between start of treatment and end of trial (EOT) visit were assigned to the on-treatment period. Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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