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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Experimental | Aflibercept 2 mg Intravitreal (IVT) injection group |
|
| Sham Injection | Sham Comparator | Sham injection group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, BAY 86-5321) | Drug | After the first aflibercept IVT injection on Day 1, 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 | It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group. | From baseline to pre-dose at Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 | 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. | From baseline to pre-dose at Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yoshida | Fukui | 910-1193 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37010901 | Derived | Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4. | |
| 33330958 | Derived | Inatani M, Higashide T, Matsushita K, Miki A, Ueki M, Iwamoto Y, Kobayashi M, Leal S; VEGA Investigators. Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial. Adv Ther. 2021 Feb;38(2):1116-1129. doi: 10.1007/s12325-020-01579-5. Epub 2020 Dec 16. |
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A total of 63 subjects were screened and 54 subjects were randomized into the aflibercept group (N=27) and the sham group (N =27).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) :
|
| FG001 | 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) :
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) :
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Pre-dose at Week 1 | It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group. | 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. | Posted | Mean | Standard Deviation | mmHg | From baseline to pre-dose at Week 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.
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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 | 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) :
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | clinical-trials-contact@bayer.com |
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| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| C005703 | salicylhydroxamic acid |
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| Sham Injection | Drug | After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met. |
|
| Gifu |
| Gifu |
| 501-1194 |
| Japan |
| Amagasaki | Hyōgo | 660-8550 | Japan |
| Himeji | Hyōgo | 671-1227 | Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kawasaki | Kanagawa | 216-8511 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Yufu | Oita Prefecture | 879-5593 | Japan |
| Hirakata | Osaka | 573-1191 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Takatsuki | Osaka | 569-8686 | Japan |
| Izumo | Shimane | 693-8501 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Mitaka | Tokyo | 181-8611 | Japan |
| Ube | Yamaguchi | 755-8505 | Japan |
| Chūō | Yamanashi | 409-3898 | Japan |
| Kyoto | 602-0841 | Japan |
| Osaka | 545-8586 | Japan |
| Protocol Violation |
|
| Treatment unblinded |
|
| BG001 | 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) :
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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) :
|
|
|
|
| Secondary | Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 | 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. | FAS | Posted | Number | Percentage of participants | From baseline to pre-dose at Week 1 |
|
|
|
|
| 3 |
| 27 |
| 10 |
| 27 |
| EG001 | 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) :
| 3 | 27 | 12 | 27 |
| EG002 | Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) | 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) :
| 0 | 27 | 6 | 27 |
| EG003 | Sham Injection Group (Till Pre-dose at Week 1) | 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) :
| 0 | 27 | 7 | 27 |
| Diabetic retinopathy | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Eating disorder | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Hyphaema | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
|
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