Idiopathic Choroidal Neovascularization Clinical Trial
Official title:
Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Iodiopathic Choroidal Neovascularization in Young Patients
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).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02857517 -
Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
|
Phase 2 |