VENERA: 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
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NVG patients Japanese patients with neovascular glaucoma |
Drug: Aflibercept (EYLEA, BAY86-5321)
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
Drug: Topical 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Fukui Hospital | Yoshida | Fukui | Japan | 910-1193 |
| 2 | Tsukazaki Hospital | Himeji | Hyogo | Japan | 671-1227 |
| 3 | Kanazawa University Hospital | Kanazawa | Ishikawa | Japan | 920-8641 |
| 4 | St. Marianna University School of Medicine Hospital | Kawasaki | Kanagawa | Japan | 216-8511 |
| 5 | Osaka University Hospital | Suita | Osaka | Japan | 565-0871 |
| 6 | Takatsuki Red Cross Hospital | Takatsuki | Osaka | Japan | 569-1096 |
| 7 | Shimane University Hospital | Izumo | Shimane | Japan | 693-8501 |
Sponsors and Collaborators
- Bayer
- Regeneron Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 19652
Study Results
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 Detail | Overall, 17 participants were screened. Of these, 16 participants were assigned and received the study treatment. |
| Arm/Group Title | Aflibercept 2 mg Intravitreal (IVT) Injection Group |
|---|---|
| Arm/Group Description | Japanese patients with neovascular glaucoma |
| Period Title: Overall Study | |
| STARTED | 16 |
| Received Treatment | 16 |
| COMPLETED | 15 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Aflibercept 2 mg Intravitreal (IVT) Injection Group |
|---|---|
| Arm/Group Description | Japanese patients with neovascular glaucoma |
| Overall Participants | 16 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
65.6
(12.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
25%
|
| Male |
12
75%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
16
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
16
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Change in Intraocular Pressure (IOP) From Baseline to Week 1 |
|---|---|
| Description | The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF). |
| Time Frame | Baseline and week 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aflibercept 2 mg Intravitreal (IVT) Injection Group |
|---|---|
| Arm/Group Description | Japanese patients with neovascular glaucoma |
| Measure Participants | 16 |
| Mean (Standard Deviation) [mmHg] |
-8.3
(7.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Aflibercept 2 mg Intravitreal (IVT) Injection Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | one-sample t-statistics | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean change |
| Estimated Value | -8.3 | |
| Confidence Interval |
(2-Sided) 95% -12.2 to -4.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Aflibercept 2 mg Intravitreal (IVT) Injection Group |
|---|---|
| Arm/Group Description | Japanese patients with neovascular glaucoma |
| Measure Participants | 16 |
| Count of Participants [Participants] |
13
81.3%
|
Adverse Events
| Time Frame | 30 days from administration in each patients | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Aflibercept 2 mg Intravitreal (IVT) Injection Group | |
| Arm/Group Description | Japanese patients with neovascular glaucoma | |
All Cause Mortality |
||
| Aflibercept 2 mg Intravitreal (IVT) Injection Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Serious Adverse Events |
||
| Aflibercept 2 mg Intravitreal (IVT) Injection Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/16 (6.3%) | |
| Infections and infestations | ||
| Pneumonia | 1/16 (6.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Aflibercept 2 mg Intravitreal (IVT) Injection Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/16 (37.5%) | |
| Eye disorders | ||
| Corneal erosion | 1/16 (6.3%) | 1 |
| Eye pain | 4/16 (25%) | 4 |
| Eye pruritus | 1/16 (6.3%) | 1 |
| Infections and infestations | ||
| Nasopharyngitis | 1/16 (6.3%) | 1 |
| Pneumonia | 1/16 (6.3%) | 1 |
| Nervous system disorders | ||
| Headache | 1/16 (6.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Bayer |
| Phone | (+)1-888-84 22937 |
| clinical-trials-contact@bayer.com |
- 19652