Clinical trial NCT02305238: Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
Official title: A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wet Macular Degeneration
Keywords: Eylea,
Aflibercept
Treat and Extend regimen
Age-related macular degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-12-02
Enrollment: 288
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) .

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.


Eligibility criteria: Inclusion Criteria:

* Japanese men and women ≥ 50 years of age
* 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:

* Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser, intraocular corticosteroids, surgical interventions (except cataract surgery more than 30 days prior to screening) or systemic use of anti-VEGF products within 3 months prior to study entry
* 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

Primary outcomes:
measure: Mean Change From Baseline in BCVA at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Percentage of Participants Who Maintained Vision at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52
timeFrame: Baseline and Week 52
measure: Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52
timeFrame: Baseline and week 52
measure: Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Asahi
country: Japan
state: Chiba
city: Sakura
country: Japan
state: Chiba
city: Koriyama
country: Japan
state: Fukushima
city: Kure
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Inashiki-gun
country: Japan
state: Ibaraki
city: Mito
country: Japan
state: Ibaraki
city: Morioka
country: Japan
state: Iwate
city: Yokohama
country: Japan
state: Kanagawa
city: Nankoku
country: Japan
state: Kochi
city: Miyakonojo
country: Japan
state: Miyazaki
city: Iida
country: Japan
state: Nagano
city: Matsumoto
country: Japan
state: Nagano
city: Hirakata
country: Japan
state: Osaka
city: Moriguchi
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Otsu
country: Japan
state: Shiga
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuoku
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Taito-ku
country: Japan
state: Tokyo
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Ube
country: Japan
state: Yamaguchi
city: Chuo
country: Japan
state: Yamanashi
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Miyazaki
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.