Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory CNV in Young Patients (ALINEA).

Summary

Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed. InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need as many injections as in AMD. ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. The first injection is mandatory. The other ones are injected only in case of active InCNV.

Timeline

Start

2016-06

Primary completion

2019-09

Completion

2019-09

Publications

• Results Kodjikian L, Abukhashabah A, Fardeau C, Tadayoni R, Brezin A, Dumas S, Weber M, Bernard L, Loria O, Decullier E, Huot L, Mathis T. Efficacy and safety of Aflibercept for the treatment of inflammatory choroidal neovascularization: The ALINEA study. Acta Ophthalmol. 2023 Feb;101(1):e43-e49. doi: 10.1111/aos.15214. Epub 2022 Jul 13.

Drugs

Indications