Glaucoma, Neovascular
Conditions
Brief summary
The researchers in this trial want 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). They also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).
Interventions
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
DRUGTopical IOP-lowering drugs
A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese men and women aged 20 years or older * Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle) * Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization
Exclusion criteria
* Patients with angle-closure due to conditions other than NVG or complete angle-closure due to NVG * Patients with a known or suspected ocular or peri-ocular infection * Patients with severe intraocular inflammation in the study eye * Women who are pregnant, suspected of being pregnant or lactating * Patients with known allergy to aflibercept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline to Week 1 | Baseline and week 1 | The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 | Baseline and week 1 | NVI 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. |
Countries
Japan
Participant flow
Recruitment details
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).
Pre-assignment details
Overall, 17 participants were screened. Of these, 16 participants were assigned and received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Aflibercept 2 mg Intravitreal (IVT) Injection Group Japanese patients with neovascular glaucoma | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Aflibercept 2 mg Intravitreal (IVT) Injection Group |
|---|---|
| Age, Continuous | 65.6 Years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 6 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Change in Intraocular Pressure (IOP) From Baseline to Week 1
The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
Time frame: Baseline and week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept 2 mg Intravitreal (IVT) Injection Group | Change in Intraocular Pressure (IOP) From Baseline to Week 1 | -8.3 mmHg | Standard Deviation 7.3 |
p-value: 0.000495% CI: [-12.2, -4.4]one-sample t-statistics
Secondary
Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1
NVI 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.
Time frame: Baseline and week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aflibercept 2 mg Intravitreal (IVT) Injection Group | Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 | 13 Participants |