AMD, Exudative Macular Degeneration
Conditions
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.
Interventions
None listed
Sponsors
Bayer
Centre Hospitalier Intercommunal Creteil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presence of flow 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 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 vascular loops 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| type of choroidal neovascularization on SD-OCT (type 1, type 2 or mixed lesions) | monthly during 13 months | — |
| measure of neovascular density on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| Intraretinal and/or subretinal fluid in SD-OCT | at month 13 | — |
| visual acuity in logmar | at baseline | Measure of best-corrected visual acuity (BCVA) measured on ETDRS |
| presence or abscence of hemorrhage, fibrosis and atrophy on fundus color photography | at 1 months | — |
| presence of flow on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence or abscence of fibrosis on fundus color photography | at 1 months | — |
| presence or abscence of atrophy on fundus color photography | at 1 months | — |
| type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) | Baseline | — |
| type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) | baseline | — |
| presence or abscence of hemorrhage on fundus color photography | at 1 months | — |
| presence of collaterals on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence of peripheral arcade on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence of arteriolization on OCTA | at month 1 | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence of vascular loops on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence of dark halo on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence of feeder vessel on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| presence of flow void on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
| choroidal thickness on EDI-OCT | monthly during 13 months | — |
| measure of neovascular area on OCTA | baseline | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time |
Countries
France
Outcome results
None listed