Trial Outcomes & Findings for Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients (NCT NCT02396316)

NCT ID: NCT02396316

Last Updated: 2017-09-15

Results Overview

It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 54 participants
• Primary outcome timeframe: From baseline to pre-dose at Week 1
• Results posted on: 2017-09-15

Participant Flow

Study was conducted at nineteen study centers in Japan, between 02 April 2015 (first subject first visit) and 06 Sep 2016 (last subject last visit).

A total of 63 subjects were screened and 54 subjects were randomized into the aflibercept group (N=27) and the sham group (N =27).

Participant milestones

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter \[ml\] \* 40 milligram per milliliter \[mg/ml\]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.	Sham Injection Group Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.
Overall Study STARTED	27	27
Overall Study Treated	27	27
Overall Study Received Sham Injection at Week 1	10	0
Overall Study Received AFL Injection at Week 1	0	22
Overall Study Received Active Injection at Week 5	4	4
Overall Study Received Active Injection at Week 9	2	1
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter \[ml\] \* 40 milligram per milliliter \[mg/ml\]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.	Sham Injection Group Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.
Overall Study Physician Decision	1	0
Overall Study Progressive disease	6	3
Overall Study Protocol Violation	0	1
Overall Study Treatment unblinded	0	1

Baseline Characteristics

Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

Baseline characteristics by cohort

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group n=27 Participants Subjects received intravitreal (IVT) injection of 2 mg (0.05 milliliter \[ml\] \* 40 milligram per milliliter \[mg/ml\]) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.	Sham Injection Group n=27 Participants Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.	Total n=54 Participants Total of all reporting groups
Age, Continuous	68.1 Years STANDARD_DEVIATION 12.7 • n=5 Participants	66.2 Years STANDARD_DEVIATION 13.7 • n=7 Participants	67.1 Years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to pre-dose at Week 1

Population: FAS: The Full Analysis Set (FAS) included all randomized subjects who have received any study drug (including sham injection) and had had a baseline and at least one post-baseline IOP measurement on a posterior date. The FAS was analyzed as randomized.

It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.

Outcome measures

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group n=27 Participants Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml \* 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.	Sham Injection Group n=27 Participants Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.
Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1	-8.5 mmHg Standard Deviation 8.7	-4.9 mmHg Standard Deviation 10.8

SECONDARY outcome

Timeframe: From baseline to pre-dose at Week 1

Population: FAS

NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.

Outcome measures

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group n=27 Participants Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml \* 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.	Sham Injection Group n=27 Participants Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator.
Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1	70.4 Percentage of participants	11.5 Percentage of participants

Adverse Events

Aflibercept 2 mg Intravitreal (IVT) Injection Group

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Sham Injection Group

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham Injection Group (Till Pre-dose at Week 1)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group n=27 participants at risk Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml \* 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)	Sham Injection Group n=27 participants at risk Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)	Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) n=27 participants at risk Subjects received IVT injection of 2 mg (0.05 ml \* 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)	Sham Injection Group (Till Pre-dose at Week 1) n=27 participants at risk Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)
Cardiac disorders Myocardial ischaemia	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Eye disorders Diabetic retinopathy	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Eye disorders Retinal artery occlusion	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Eye disorders Retinal vein occlusion	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Psychiatric disorders Eating disorder	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.

Other adverse events

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group n=27 participants at risk Subjects received intravitreal (IVT) injection of 2 mg (0.05 ml \* 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)	Sham Injection Group n=27 participants at risk Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)	Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) n=27 participants at risk Subjects received IVT injection of 2 mg (0.05 ml \* 40 mg/ml) aflibercept on Day 1. Then, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)	Sham Injection Group (Till Pre-dose at Week 1) n=27 participants at risk Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met. Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) : * IOP higher than 21mmHg; * Incomplete regression of iris neovascularization and; * Aflibercept IVT deemed necessary by the investigator. (AE time frame: from the first dose of study drug until pre-dose at Week 1)
Eye disorders Conjunctival haemorrhage	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Eye disorders Eye pain	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	14.8% 4/27 • Number of events 5 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Eye disorders Hyphaema	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Eye disorders Punctate keratitis	7.4% 2/27 • Number of events 4 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	11.1% 3/27 • Number of events 4 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Gastrointestinal disorders Constipation	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Gastrointestinal disorders Diarrhoea	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
General disorders Injection site pain	7.4% 2/27 • Number of events 3 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 3 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Injury, poisoning and procedural complications Procedural pain	11.1% 3/27 • Number of events 4 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Investigations Intraocular pressure increased	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.
Nervous system disorders Headache	3.7% 1/27 • Number of events 1 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	0.00% 0/27 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.	7.4% 2/27 • Number of events 2 • Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.

Additional Information

Therapeutic Area Head

Bayer

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place