Trial Outcomes & Findings for Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied (NCT NCT03639675)
NCT ID: NCT03639675
Last Updated: 2020-03-03
Results Overview
The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
COMPLETED
PHASE3
16 participants
Baseline and week 1
2020-03-03
Participant Flow
Study was conducted at 7 study sites in Japan from 3-Oct-2018 (first subject's first visit) to 14-Mar-2019 (last subject's last visit).
Overall, 17 participants were screened. Of these, 16 participants were assigned and received the study treatment.
Participant milestones
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
Japanese patients with neovascular glaucoma
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Received Treatment
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
Japanese patients with neovascular glaucoma
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied
Baseline characteristics by cohort
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
n=16 Participants
Japanese patients with neovascular glaucoma
|
|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 1The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
Outcome measures
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
n=16 Participants
Japanese patients with neovascular glaucoma
|
|---|---|
|
Change in Intraocular Pressure (IOP) From Baseline to Week 1
|
-8.3 mmHg
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline and week 1NVI Grade: 0=No iris neovascularization; 1=Fine surface neovascularization of the pupillary zone of the iris involving less than two quadrants; 2=Surface neovascularization of the pupillary zone of the iris involving more than two quadrants; 3=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving one to three quadrants; 4=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving more than three quadrants. The change in NVI grades categorized to "Improved" means improvement by at least one grade from baseline.
Outcome measures
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
n=16 Participants
Japanese patients with neovascular glaucoma
|
|---|---|
|
Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1
|
13 Participants
|
Adverse Events
Aflibercept 2 mg Intravitreal (IVT) Injection Group
Serious adverse events
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
n=16 participants at risk
Japanese patients with neovascular glaucoma
|
|---|---|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • 30 days from administration in each patients
|
Other adverse events
| Measure |
Aflibercept 2 mg Intravitreal (IVT) Injection Group
n=16 participants at risk
Japanese patients with neovascular glaucoma
|
|---|---|
|
Eye disorders
Corneal erosion
|
6.2%
1/16 • Number of events 1 • 30 days from administration in each patients
|
|
Eye disorders
Eye pain
|
25.0%
4/16 • Number of events 4 • 30 days from administration in each patients
|
|
Eye disorders
Eye pruritus
|
6.2%
1/16 • Number of events 1 • 30 days from administration in each patients
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Number of events 1 • 30 days from administration in each patients
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • 30 days from administration in each patients
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • 30 days from administration in each patients
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period described in the contract with the head of the medical institution based on J-GCP (Good clinical practice). The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER