Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
NCT ID: NCT02305238
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
288 participants
INTERVENTIONAL
2014-12-19
2017-12-20
Brief Summary
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To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2 Weeks adjustment
Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.
4 Weeks adjustment
Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.
Eligibility Criteria
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Inclusion Criteria
* Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD, including juxta-foveal lesions that affect the fovea as evidenced by fluorescein angiography (FA) in the study eye
* Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study eye
Exclusion Criteria
* Active or suspected infection in or surrounding of the study eye
* Active severe intraocular inflammation in the study eye
* Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
* Ocular condition in the study eye which may impact vision and confound study outcomes
50 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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Ichinomiya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Asahi, Chiba, Japan
Sakura, Chiba, Japan
Kōriyama, Fukushima, Japan
Kure, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Inashiki-gun, Ibaraki, Japan
Mito, Ibaraki, Japan
Morioka, Iwate, Japan
Yokohama, Kanagawa, Japan
Nankoku, Kochi, Japan
Miyakonojō, Miyazaki, Japan
Iida, Nagano, Japan
Matsumoto, Nagano, Japan
Hirakata, Osaka, Japan
Moriguchi, Osaka, Japan
Sayama, Osaka, Japan
Takatsuki, Osaka, Japan
Ōtsu, Shiga, Japan
Chiyoda-ku, Tokyo, Japan
Chuoku, Tokyo, Japan
Hachiōji, Tokyo, Japan
Mitaka, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Taito-ku, Tokyo, Japan
Shimonoseki, Yamaguchi, Japan
Ube, Yamaguchi, Japan
Chūō, Yamanashi, Japan
Fukuoka, , Japan
Fukuoka, , Japan
Miyazaki, , Japan
Okayama, , Japan
Osaka, , Japan
Osaka, , Japan
Countries
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References
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Okada AA, Takahashi K, Ohji M, Moon SC, Machewitz T, Sasaki K; ALTAIR Study Investigators. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup. Adv Ther. 2022 Jun;39(6):2984-2998. doi: 10.1007/s12325-022-02162-w. Epub 2022 May 3.
Ohji M, Okada AA, Sasaki K, Moon SC, Machewitz T, Takahashi K; ALTAIR Investigators. Relationship between retinal fluid and visual acuity in patients with exudative age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: subgroup and post-hoc analyses from the ALTAIR study. Graefes Arch Clin Exp Ophthalmol. 2021 Dec;259(12):3637-3647. doi: 10.1007/s00417-021-05293-y. Epub 2021 Jul 20.
Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y; ALTAIR Investigators. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial. Adv Ther. 2020 Mar;37(3):1173-1187. doi: 10.1007/s12325-020-01236-x. Epub 2020 Feb 3.
Related Links
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Other Identifiers
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17668
Identifier Type: -
Identifier Source: org_study_id
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