CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

Study Overview
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Brief Summary
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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.

Official Title
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CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

Conditions
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AMD, Exudative Macular Degeneration

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of flow on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month1 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of collaterals on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of peripheral arcade on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of arteriolization on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of vascular loops on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of dark halo on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of feeder vessel on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| presence of flow void on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| measure of neovascular area on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | baseline | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 1 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 2 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 3 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 4 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 5 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 6 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 7 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 8 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 9 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 10 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 11 | 
| measure of neovascular density on OCTA | high flow on OCTA corresponding to the neovascular network with vascular remodeling over time | at month 12 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 13 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at baseline | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 1 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 2 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 3 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 4 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 5 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 6 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 7 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 8 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 9 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 10 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 11 | 
| Intraretinal and/or subretinal fluid in SD-OCT |  | at month 12 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at baseline | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 1 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 2 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 3 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 4 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 5 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 6 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 7 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 8 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 9 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 10 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 11 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 12 | 
| visual acuity in logmar | Measure of best-corrected visual acuity (BCVA) measured on ETDRS | at month 13 | 
| presence or abscence of hemorrhage, fibrosis and atrophy on fundus color photography |  | at 1 months | 
| presence or abscence of hemorrhage on fundus color photography |  | at 1 months | 
| presence or abscence of fibrosis on fundus color photography |  | at 1 months | 
| presence or abscence of atrophy on fundus color photography |  | at 1 months | 
| presence or abscence of hemorrhage on fundus color photography |  | at 13 months | 
| presence or abscence of fibrosis on fundus color photography |  | at 13 months | 
| presence or abscence of atrophy on fundus color photography |  | at 13 months | 
| type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) |  | Baseline | 
| 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) |  | baseline | 
| type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) |  | at month 13 | 
| choroidal thickness on EDI-OCT |  | monthly during 13 months | 
| type of choroidal neovascularization on SD-OCT (type 1, type 2 or mixed lesions) |  | monthly during 13 months |