Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
NCT ID: NCT02396316
Last Updated: 2017-09-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2015-04-02
2016-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aflibercept
Aflibercept 2 mg Intravitreal (IVT) injection group
Aflibercept (Eylea, BAY 86-5321)
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.
Sham Injection
Sham injection group
Sham Injection
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.
Interventions
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Aflibercept (Eylea, BAY 86-5321)
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.
Sham Injection
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.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed as having Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
* Patients with Intraocular pressure (IOP) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization.
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Yoshida, Fukui, Japan
Gifu, Gifu, Japan
Amagasaki, Hyōgo, Japan
Himeji, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kanazawa, Ishikawa-ken, Japan
Kawasaki, Kanagawa, Japan
Sendai, Miyagi, Japan
Yufu, Oita Prefecture, Japan
Hirakata, Osaka, Japan
Suita, Osaka, Japan
Takatsuki, Osaka, Japan
Izumo, Shimane, Japan
Bunkyo-ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Ube, Yamaguchi, Japan
Chūō, Yamanashi, Japan
Kyoto, , Japan
Osaka, , Japan
Countries
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References
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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.
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.
Other Identifiers
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17584
Identifier Type: -
Identifier Source: org_study_id