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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated with a TAE regimen until 20 weeks (3 mandatory injections at inclusion, week 8 and 20 with reinjection at week 4, 12 and 16 only in case of CNV activity). Then, a PRN regimen is considered until 52 weeks (reinjection in case of CNV activity). Therefore, each patient receives between 3 and 13 injections in the whole study.
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, France
Mean change in best-corrected visual acuity (BCVA) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52
BCVA is measured on the ETDRS scale at an initial distance of 4 meters
Time frame: 52 weeks
Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
Time frame: 24 weeks
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24
Time frame: 24 weeks
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52
Time frame: 52 weeks
Mean number of injections per patient during the TAE regimen (until week 20)
Time frame: 20 weeks
Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20)
Time frame: 32 weeks
Mean total number of injections per patient during the study
Time frame: 52 weeks
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24
Time frame: 24 weeks
Mean change in CRT in micrometers measured with SD-OCT from baseline to week 52
Time frame: 52 weeks
Mean change in neovascular lesion size and morphology measured with fluorescein and/or indocyanin green angiography from baseline to week 52
Time frame: 52 weeks
Side-effects observed during the study
Time frame: 52 weeks
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