Trial Outcomes & Findings for A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated. (NCT NCT03238963)
NCT ID: NCT03238963
Last Updated: 2021-06-04
Results Overview
Percentage of participants with any ocular adverse events over the on-treatment period was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.
Results posted on
2021-06-04
Participant Flow
A study evaluated safety and tolerability of 12-week treatment of oral BI 1467335 compared to placebo in patients with moderately severe to severe non-proliferative diabetic retinopathy without center-involved diabetic macular edema and explored the efficacy of BI 1467335 on improvement of diabetic retinopathy.
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 |
BI 1467335 10 mg
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
BI 1467335 10 mg
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Overall Study
Prohibited medication given due to hospital stay
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
Baseline characteristics by cohort
| Measure |
BI 1467335 10 mg
n=40 Participants
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
n=39 Participants
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
53.1 Years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
52.8 Years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.Population: Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
Percentage of participants with any ocular adverse events over the on-treatment period was reported.
Outcome measures
| Measure |
BI 1467335 10 mg
n=40 Participants
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
n=39 Participants
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Percentage of Participants With Any Ocular Adverse Events Over the On-treatment Period
|
35.0 Percentage of participants
|
23.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 12.Population: Full analysis set (FAS): the FAS consists of all the patients who were randomized, treated with at least one dose of BI 1467335/placebo and have baseline and one on-treatment Diabetic Retinopathy Severity Scale assessment. Only patients with non-missing endpoint results were included in the analysis.
7-field or modified 4-field digital fundus photographs was obtained from both eyes by a qualified person according to the imaging manual to collect all data for the assessment of the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS). The images was sent to the independent central reading center who performs the grading on the basis of the DRSS. The DRSS ranges from level 10 (Diabetic retinopathy absent) to level 85 (advanced proliferative Diabetic retinopathy).
Outcome measures
| Measure |
BI 1467335 10 mg
n=35 Participants
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
n=34 Participants
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Percentage of Participants With at Least 2 Steps Improvement From Baseline in the Study Eye on the Diabetic Retinopathy Severity Scale (DRSS) at Week 12
|
5.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.Population: Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
Percentage of participants with adverse events other than ocular adverse events over on-treatment period was reported.
Outcome measures
| Measure |
BI 1467335 10 mg
n=40 Participants
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
n=39 Participants
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Percentage of Participants With Adverse Events Other Than Ocular Adverse Events Over On-treatment Period
|
55.0 Percentage of participants
|
82.1 Percentage of participants
|
Adverse Events
BI 1467335 10 mg
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 1467335 10 mg
n=40 participants at risk
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
n=39 participants at risk
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Eye disorders
Visual acuity reduced
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
2.6%
1/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
2.6%
1/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
2.6%
1/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Liver function test increased
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
2.6%
1/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Nervous system disorders
Dysarthria
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
0.00%
0/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
Other adverse events
| Measure |
BI 1467335 10 mg
n=40 participants at risk
2 film coated tablets of 5 milligram (mg) BI 1467335 (Total: 10 mg) were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
Placebo
n=39 participants at risk
2 film coated tablets of matching placebo were taken orally once daily for a treatment period of 12 weeks with 12 weeks of follow-up.
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
7.5%
3/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
7.7%
3/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
15.4%
6/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Infections and infestations
Localised infection
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
12.8%
5/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Blood glucose increased
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
7.7%
3/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Glucose urine present
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Lipase increased
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Investigations
Protein urine present
|
0.00%
0/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
7.7%
3/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
5.1%
2/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Nervous system disorders
Headache
|
17.5%
7/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
12.8%
5/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
10.3%
4/39 • From first dose of study drug until end of follow-up period, up to 24 weeks.
Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
|
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