CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
- Conditions
- Exudative Macular DegenerationAMD
- Registration Number
- NCT03803631
- Lead Sponsor
- Centre Hospitalier Intercommunal Creteil
- Brief Summary
The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 49
- Naïve patients
- Type 1 or type 2 Choroidal NeoVascularization (CNV)
- Age ≥ 55 years
- Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
- At the time of inclusion, multimodal imaging should reveal exudative features
- Exudative AMD diagnosis established between 1 and 7 days before inclusion
- Monitored monthly
- Loading phase then bimonthly retreatment.
- Signed Informed Consent.
- Patient covered by the French Health Insurance
- Polypoidal choroidal vasculopathy
- Type 3 neovascularization
- Choroidal neovascularization attributable to causes other than AMD
- Macular hematoma
- Pigment epithelial detachment higher than 150µm
- Fibrosis > 50% lesion on fundus color photography, fibroglial scar
- Media opacity annoying acquisition
- Retinal vascular occlusion
- Diabetic retinopathy
- Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
- Refractive error >-6D
- Active intraocular inflammation in the study eye
- Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
- Patient taking part in an interventional study at the time of enrolment.
- Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
- Pregnant and lactating women
- Stroke and/or myocardial infarction 3 months before inclusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method presence of vascular loops on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA at month 13 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
- Secondary Outcome Measures
Name Time Method choroidal thickness on EDI-OCT monthly during 13 months presence of peripheral arcade on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Intraretinal and/or subretinal fluid in SD-OCT at month 12 visual acuity in logmar at month 13 Measure of best-corrected visual acuity (BCVA) measured on ETDRS
presence or abscence of hemorrhage on fundus color photography at 13 months type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) at month 13 type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) at month 13 presence or abscence of hemorrhage, fibrosis and atrophy on fundus color photography at 1 months presence of vascular loops on OCTA at month 10 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence or abscence of fibrosis on fundus color photography at 13 months presence of collaterals on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA at month 12 high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence or abscence of atrophy on fundus color photography at 13 months type of choroidal neovascularization on SD-OCT (type 1, type 2 or mixed lesions) monthly during 13 months
Trial Locations
- Locations (5)
Hôpital Pellegrin, CHU de Bordeaux
🇫🇷Bordeaux, France
CHI de Créteil
🇫🇷Créteil, France
Hôpital Lariboisière, APHP
🇫🇷Paris, France
Hôpital La Croix Rousse
🇫🇷Lyon, France
Centre Ophtalmologique d'Imagerie et de Laser,
🇫🇷Paris, France