Trial Outcomes & Findings for HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (NCT NCT04424290)
NCT ID: NCT04424290
Last Updated: 2024-05-22
Results Overview
Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
From drug administration (day 1) till day 8, Up to 7±2 days.
Results posted on
2024-05-22
Participant Flow
This was a trial consisting of a non-randomised, uncontrolled, open label single-rising dose part and a randomised, shamcontrolled, single-blind multiple dosing part.
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
| Measure |
Single-rising Dose Part - Low Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
Multiple Dosing Part - Sham
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.
|
Multiple Dosing Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
10
|
22
|
|
Overall Study
Treated
|
3
|
3
|
6
|
10
|
21
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
7
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Single-rising Dose Part - Low Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
Multiple Dosing Part - Sham
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.
|
Multiple Dosing Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Not treated
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other than listed
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia
Baseline characteristics by cohort
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
n=6 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
Multiple Dosing Part - Sham
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.
|
Multiple Dosing Part - High Dose BI 764524
n=21 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 15.0 • n=99 Participants
|
61.0 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
60.8 years
STANDARD_DEVIATION 6.0 • n=206 Participants
|
60.0 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 13.2 • n=31 Participants
|
60.2 years
STANDARD_DEVIATION 10.6 • n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
33 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
35 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From drug administration (day 1) till day 8, Up to 7±2 days.Population: Treated set: all patients who were randomised and treated with at least one dose of study drug.
Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
n=6 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From drug administration (day 1) till End of Trial, up to 23 weeks.Population: Treated set: all patients who were randomised and treated with at least one dose of study drug.
Multiple dosing (MD) part - the number of patients with drug-related Adverse Events (AEs) from drug administration until End of Trial.
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=21 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
Multiple Dosing (MD) Part - the Number of Patients With Drug-related Adverse Events (AEs) From Drug Administration Until End of Trial.
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From drug administration (day 1) till End of Trial, up to 15 weeks.Population: Treated set: all patients who were randomised and treated with at least one dose of study drug.
SRD part - Number of patients with drug-related Adverse Events at End of Trial.
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
n=6 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
SRD Part - Number of Patients With Drug-related Adverse Events at End of Trial
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From drug administration (day 1) till End of Trial, up to 15 weeks.Population: Treated set: all patients who were randomised and treated with at least one dose of study drug.
SRD part - Number of patients with ocular Adverse Events (eye disorders) at End of Trial.
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=3 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
n=6 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
SRD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
|
2 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From drug administration (day 1) till End of Trial, up to 23 weeks.Population: Treated set: all patients who were randomised and treated with at least one dose of study drug.
MD part - Number of patients with ocular Adverse Events (eye disorders) at End of Trial.
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=21 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
|
4 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 5 (day 85±7).Population: All patients who were randomised and treated with at least one dose of study drug and with baseline and at least 1 on-treatment post-baseline value.
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in full thickness retina (FTR) at Visit 5. Results calculated as \[Baseline data\]-\[Visit 5 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=7 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=16 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 5
|
0.0167 Millimeter^2
Standard Deviation 0.0197
|
-0.0004 Millimeter^2
Standard Deviation 0.0381
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 5 (day 85±7).Population: All patients who were randomised and treated with at least one dose of study drug and with baseline and at least 1 on-treatment post-baseline value.
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial vascular complex (SVC) at Visit 5. Results calculated as \[Baseline data\]-\[Visit 5 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=8 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=15 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 5
|
0.0489 Millimeter^2
Standard Deviation 0.0740
|
0.0741 Millimeter^2
Standard Deviation 0.1130
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 7 (day 155±7).Population: All patients who were randomised and treated with at least one dose of study drug and with baseline and at least 1 on-treatment post-baseline value.
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in full thickness retina (FTR) at Visit 7. Results calculated as \[Baseline data\]-\[Visit 7 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=7 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=16 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 7
|
0.0133 Millimeter^2
Standard Deviation 0.0152
|
-0.0027 Millimeter^2
Standard Deviation 0.0345
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 7 (day 155±7).Population: All patients who were randomised and treated with at least one dose of study drug and with baseline and at least 1 on-treatment post-baseline value.
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial vascular complex (SVC) at Visit 7. Results calculated as \[Baseline data\]-\[Visit 7 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=7 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=14 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 7
|
0.1233 Millimeter^2
Standard Deviation 0.1473
|
0.1101 Millimeter^2
Standard Deviation 0.1445
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 3 (day 29±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
Change from baseline of best corrected visual acuity (BCVA) at Visit 3. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as \[Baseline data\]-\[Visit 3 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=20 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 3
|
1.5 Number of letters
Standard Deviation 13.5
|
1.1 Number of letters
Standard Deviation 5.2
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 4 (day 57±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
Change from baseline of best corrected visual acuity (BCVA) at Visit 4. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as \[Baseline data\]-\[Visit 4 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=20 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 4
|
-4.1 Number of letters
Standard Deviation 24.4
|
1.4 Number of letters
Standard Deviation 6.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 5 (day 85±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
Change from baseline of best corrected visual acuity (BCVA) at Visit 5. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 5 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as \[Baseline data\]-\[Visit 5 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=17 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 5
|
3.9 Number of letters
Standard Deviation 10.7
|
2.5 Number of letters
Standard Deviation 6.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 6 (day 113±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
Change from baseline of best corrected visual acuity (BCVA) at Visit 6. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 6 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as \[Baseline data\]-\[Visit 6 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=17 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 6
|
2.6 Number of letters
Standard Deviation 9.6
|
3.1 Number of letters
Standard Deviation 9.8
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 7 (day 155±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
Change from baseline of best corrected visual acuity (BCVA) at Visit 7. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 7 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as \[Baseline data\]-\[Visit 7 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=19 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 7
|
4.9 Number of letters
Standard Deviation 9.3
|
3.4 Number of letters
Standard Deviation 7.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 3 (day 29±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 3. Results calculated as \[Baseline data\]-\[Visit 3 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=10 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=20 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 3
|
1.6 Micrometer
Standard Deviation 4.9
|
0.9 Micrometer
Standard Deviation 7.2
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 4 (day 57±7)Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 4. Results calculated as \[Baseline data\]-\[Visit 4 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=9 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=19 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 4
|
-1.7 Micrometer
Standard Deviation 5.1
|
0.2 Micrometer
Standard Deviation 7.2
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 5 (day 85±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 5. Results calculated as \[Baseline data\]-\[Visit 5 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=9 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=17 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 5
|
-2.9 Micrometer
Standard Deviation 5.3
|
3.9 Micrometer
Standard Deviation 12.8
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 6 (day 113±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 6. Results calculated as \[Baseline data\]-\[Visit 6 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=9 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=17 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 6
|
-3.0 Micrometer
Standard Deviation 3.8
|
8.6 Micrometer
Standard Deviation 25.1
|
—
|
SECONDARY outcome
Timeframe: Baseline (day 0) and Visit 7 (day 155±7).Population: All patients who were randomised and treated with at least one dose of study drug, with data for the baseline and the corresponding visit.
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 7. Results calculated as \[Baseline data\]-\[Visit 7 data\].
Outcome measures
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=9 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=19 Participants
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
|---|---|---|---|
|
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 7
|
-3.2 Micrometer
Standard Deviation 7.4
|
3.5 Micrometer
Standard Deviation 9.5
|
—
|
Adverse Events
Single-rising Dose Part - Low Dose BI 764524
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Single-rising Dose Part - Medium Dose BI 764524
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single-rising Dose Part - High Dose BI 764524
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Multiple Dosing Part - Sham
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Multiple Dosing Part - High Dose BI 764524
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=3 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=3 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
n=6 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
Multiple Dosing Part - Sham
n=10 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.
|
Multiple Dosing Part - High Dose BI 764524
n=21 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.
|
|---|---|---|---|---|---|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
20.0%
2/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
General disorders
Injection site inflammation
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
4.8%
1/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
4.8%
1/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
4.8%
1/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
Other adverse events
| Measure |
Single-rising Dose Part - Low Dose BI 764524
n=3 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
|
Single-rising Dose Part - Medium Dose BI 764524
n=3 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
|
Single-rising Dose Part - High Dose BI 764524
n=6 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
|
Multiple Dosing Part - Sham
n=10 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.
|
Multiple Dosing Part - High Dose BI 764524
n=21 participants at risk
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Episcleritis
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Iris neovascularisation
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Vitreal cells
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
33.3%
2/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
9.5%
2/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
9.5%
2/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Investigations
Blood folate increased
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
9.5%
2/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Investigations
Blood glucose decreased
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
20.0%
2/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
9.5%
2/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
10.0%
1/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/3 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
16.7%
1/6 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
0.00%
0/10 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
4.8%
1/21 • From time of administration till the End of Trial, up to 15 weeks for the SRD part and up to 23 weeks for the MD part.
Treated set: all patients who were randomised and treated with at least one dose of study drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- 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.
- Publication restrictions are in place
Restriction type: OTHER