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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVG patients | Experimental | Japanese patients with neovascular glaucoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (EYLEA, BAY86-5321) | Drug | 2 mg (0.05 mL), Intravitreal injection (IVT), single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Fukui Hospital | Yoshida | Fukui | 910-1193 | Japan | ||
| Tsukazaki Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33330959 | Derived | Inatani M, Higashide T, Matsushita K, Nagasato D, Takagi H, Ueki M, Takai Y, Miyazaki K, Iwamoto Y, Kobayashi M, Leal S. Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from the VENERA Study. Adv Ther. 2021 Feb;38(2):1106-1115. doi: 10.1007/s12325-020-01580-y. Epub 2020 Dec 16. |
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Overall, 17 participants were screened. Of these, 16 participants were assigned and received the study treatment.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | Japanese patients with neovascular glaucoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2018 | Feb 5, 2020 |
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| Topical IOP-lowering drugs | Drug | 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 |
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| Baseline and week 1 |
| Himeji |
| Hyōgo |
| 671-1227 |
| Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| St. Marianna University School of Medicine Hospital | Kawasaki | Kanagawa | 216-8511 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1096 | Japan |
| Shimane University Hospital | Izumo | Shimane | 693-8501 | Japan |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | Japanese patients with neovascular glaucoma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | mmHg | Baseline and week 1 |
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| 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. | Posted | Count of Participants | Participants | Baseline and week 1 |
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30 days from administration in each patients
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | Japanese patients with neovascular glaucoma | 0 | 16 | 1 | 16 | 6 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal erosion | Eye disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2018 | Feb 5, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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