Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients

Summary

After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (\<50 years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown. This is a rare and severe disease, which can lead to blindness. ICNV 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 Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not need as many injections as in AMD. INTUITION 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 ICNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept are initiated with a Treat \& Extend (TAE) regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in case of CNV activity).

Timeline

Start

2015-07-06

Primary completion

2019-07-11

Completion

2019-07-11

Publications

• Results Kodjikian L, Tadayoni R, Souied EH, Baillif S, Milazzo S, Dumas S, Uzzan J, Bernard L, Decullier E, Huot L, Mathis T. EFFICACY AND SAFETY OF AFLIBERCEPT FOR THE TREATMENT OF IDIOPATHIC CHOROIDAL NEOVASCULARIZATION IN YOUNG PATIENTS: The INTUITION Study. Retina. 2022 Feb 1;42(2):290-297. doi: 10.1097/IAE.0000000000003310.

Drugs

Indications