drugset / Trial / NCT02305238
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-12-19
- Primary completion
- 2016-12-22
- Completion
- 2017-12-20
Publications
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |