Clinical trial NCT03803631: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
Official title: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AMD
Exudative Macular Degeneration
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2019-01-14
Enrollment: 49
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with wet-AMD (NVC type 1 or 2) diagnosed maximum one week before inclusion and for whom Aflibercept in intra-vitreal injection technic has been prescribed.

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.


Eligibility criteria: 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

Primary outcomes:
measure: presence of flow on OCTA
timeFrame: at month 13
measure: presence of collaterals on OCTA
timeFrame: at month 13
measure: presence of peripheral arcade on OCTA
timeFrame: at month 13
measure: presence of arteriolization on OCTA
timeFrame: at month 13
measure: presence of vascular loops on OCTA
timeFrame: at month 13
measure: presence of dark halo on OCTA
timeFrame: at month 13
measure: presence of feeder vessel on OCTA
timeFrame: at month 13
measure: presence of flow void on OCTA
timeFrame: at month 13
measure: measure of neovascular area on OCTA
timeFrame: at month 13
measure: measure of neovascular density on OCTA
timeFrame: at month 13
Secondary outcomes:
measure: presence of flow on OCTA
timeFrame: baseline
measure: presence of flow on OCTA
timeFrame: at month 1
measure: presence of flow on OCTA
timeFrame: at month 2
measure: presence of flow on OCTA
timeFrame: at month 3
measure: presence of flow on OCTA
timeFrame: at month 4
measure: presence of flow on OCTA
timeFrame: at month 5
measure: presence of flow on OCTA
timeFrame: at month 6
measure: presence of flow on OCTA
timeFrame: at month 7
measure: presence of flow on OCTA
timeFrame: at month 8
measure: presence of flow on OCTA
timeFrame: at month 9
measure: presence of flow on OCTA
timeFrame: at month 10
measure: presence of flow on OCTA
timeFrame: at month 11
measure: presence of flow on OCTA
timeFrame: at month 12
measure: presence of collaterals on OCTA
timeFrame: baseline
measure: presence of collaterals on OCTA
timeFrame: at month1
measure: presence of collaterals on OCTA
timeFrame: at month 2
measure: presence of collaterals on OCTA
timeFrame: at month 3
measure: presence of collaterals on OCTA
timeFrame: at month 4
measure: presence of collaterals on OCTA
timeFrame: at month 5
measure: presence of collaterals on OCTA
timeFrame: at month 6
measure: presence of collaterals on OCTA
timeFrame: at month 7
measure: presence of collaterals on OCTA
timeFrame: at month 8
measure: presence of collaterals on OCTA
timeFrame: at month 9
measure: presence of collaterals on OCTA
timeFrame: at month 10
measure: presence of collaterals on OCTA
timeFrame: at month 11
measure: presence of collaterals on OCTA
timeFrame: at month 12
measure: presence of peripheral arcade on OCTA
timeFrame: baseline
measure: presence of peripheral arcade on OCTA
timeFrame: at month 1
measure: presence of peripheral arcade on OCTA
timeFrame: at month 2
measure: presence of peripheral arcade on OCTA
timeFrame: at month 3
measure: presence of peripheral arcade on OCTA
timeFrame: at month 4
measure: presence of peripheral arcade on OCTA
timeFrame: at month 5
measure: presence of peripheral arcade on OCTA
timeFrame: at month 6
measure: presence of peripheral arcade on OCTA
timeFrame: at month 7
measure: presence of peripheral arcade on OCTA
timeFrame: at month 8
measure: presence of peripheral arcade on OCTA
timeFrame: at month 9
measure: presence of peripheral arcade on OCTA
timeFrame: at month 10
measure: presence of peripheral arcade on OCTA
timeFrame: at month 11
measure: presence of peripheral arcade on OCTA
timeFrame: at month 12
measure: presence of arteriolization on OCTA
timeFrame: at month 1
measure: presence of arteriolization on OCTA
timeFrame: at month 2
measure: presence of arteriolization on OCTA
timeFrame: at month 3
measure: presence of arteriolization on OCTA
timeFrame: at month 4
measure: presence of arteriolization on OCTA
timeFrame: at month 5
measure: presence of arteriolization on OCTA
timeFrame: at month 6
measure: presence of arteriolization on OCTA
timeFrame: at month 7
measure: presence of arteriolization on OCTA
timeFrame: at month 8
measure: presence of arteriolization on OCTA
timeFrame: at month 9
measure: presence of arteriolization on OCTA
timeFrame: at month 10
measure: presence of arteriolization on OCTA
timeFrame: at month 11
measure: presence of arteriolization on OCTA
timeFrame: at month 12
measure: presence of vascular loops on OCTA
timeFrame: baseline
measure: presence of vascular loops on OCTA
timeFrame: at month 1
measure: presence of vascular loops on OCTA
timeFrame: at month 2
measure: presence of vascular loops on OCTA
timeFrame: at month 3
measure: presence of vascular loops on OCTA
timeFrame: at month 4
measure: presence of vascular loops on OCTA
timeFrame: at month 5
measure: presence of vascular loops on OCTA
timeFrame: at month 6
measure: presence of vascular loops on OCTA
timeFrame: at month 7
measure: presence of vascular loops on OCTA
timeFrame: at month 8
measure: presence of vascular loops on OCTA
timeFrame: at month 9
measure: presence of vascular loops on OCTA
timeFrame: at month 10
measure: presence of dark halo on OCTA
timeFrame: baseline
measure: presence of dark halo on OCTA
timeFrame: at month 1
measure: presence of dark halo on OCTA
timeFrame: at month 2
measure: presence of dark halo on OCTA
timeFrame: at month 3
measure: presence of dark halo on OCTA
timeFrame: at month 4
measure: presence of dark halo on OCTA
timeFrame: at month 5
measure: presence of dark halo on OCTA
timeFrame: at month 6
measure: presence of dark halo on OCTA
timeFrame: at month 7
measure: presence of dark halo on OCTA
timeFrame: at month 8
measure: presence of dark halo on OCTA
timeFrame: at month 9
measure: presence of dark halo on OCTA
timeFrame: at month 10
measure: presence of dark halo on OCTA
timeFrame: at month 11
measure: presence of dark halo on OCTA
timeFrame: at month 12
measure: presence of feeder vessel on OCTA
timeFrame: baseline
measure: presence of feeder vessel on OCTA
timeFrame: at month 1
measure: presence of feeder vessel on OCTA
timeFrame: at month 2
measure: presence of feeder vessel on OCTA
timeFrame: at month 3
measure: presence of feeder vessel on OCTA
timeFrame: at month 4
measure: presence of feeder vessel on OCTA
timeFrame: at month 5
measure: presence of feeder vessel on OCTA
timeFrame: at month 6
measure: presence of feeder vessel on OCTA
timeFrame: at month 7
measure: presence of feeder vessel on OCTA
timeFrame: at month 8
measure: presence of feeder vessel on OCTA
timeFrame: at month 9
measure: presence of feeder vessel on OCTA
timeFrame: at month 10
measure: presence of feeder vessel on OCTA
timeFrame: at month 11
measure: presence of feeder vessel on OCTA
timeFrame: at month 12
measure: presence of flow void on OCTA
timeFrame: baseline
measure: presence of flow void on OCTA
timeFrame: at month 1
measure: presence of flow void on OCTA
timeFrame: at month 2
measure: presence of flow void on OCTA
timeFrame: at month 3
measure: presence of flow void on OCTA
timeFrame: at month 4
measure: presence of flow void on OCTA
timeFrame: at month 5
measure: presence of flow void on OCTA
timeFrame: at month 6
measure: presence of flow void on OCTA
timeFrame: at month 7
measure: presence of flow void on OCTA
timeFrame: at month 8
measure: presence of flow void on OCTA
timeFrame: at month 9
measure: presence of flow void on OCTA
timeFrame: at month 10
measure: presence of flow void on OCTA
timeFrame: at month 11
measure: presence of flow void on OCTA
timeFrame: at month 12
measure: measure of neovascular area on OCTA
timeFrame: baseline
measure: measure of neovascular area on OCTA
timeFrame: at month 1
measure: measure of neovascular area on OCTA
timeFrame: at month 2
measure: measure of neovascular area on OCTA
timeFrame: at month 3
measure: measure of neovascular area on OCTA
timeFrame: at month 4
measure: measure of neovascular area on OCTA
timeFrame: at month 5
measure: measure of neovascular area on OCTA
timeFrame: at month 6
measure: measure of neovascular area on OCTA
timeFrame: at month 7
measure: measure of neovascular area on OCTA
timeFrame: at month 8
measure: measure of neovascular area on OCTA
timeFrame: at month 9
measure: measure of neovascular area on OCTA
timeFrame: at month 10
measure: measure of neovascular area on OCTA
timeFrame: at month 11
measure: measure of neovascular area on OCTA
timeFrame: at month 12
measure: measure of neovascular density on OCTA
timeFrame: baseline
measure: measure of neovascular density on OCTA
timeFrame: at month 1
measure: measure of neovascular density on OCTA
timeFrame: at month 2
measure: measure of neovascular density on OCTA
timeFrame: at month 3
measure: measure of neovascular density on OCTA
timeFrame: at month 4
measure: measure of neovascular density on OCTA
timeFrame: at month 5
measure: measure of neovascular density on OCTA
timeFrame: at month 6
measure: measure of neovascular density on OCTA
timeFrame: at month 7
measure: measure of neovascular density on OCTA
timeFrame: at month 8
measure: measure of neovascular density on OCTA
timeFrame: at month 9
measure: measure of neovascular density on OCTA
timeFrame: at month 10
measure: measure of neovascular density on OCTA
timeFrame: at month 11
measure: measure of neovascular density on OCTA
timeFrame: at month 12
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 13
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at baseline
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 1
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 2
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 3
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 4
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 5
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 6
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 7
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 8
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 9
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 10
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 11
measure: Intraretinal and/or subretinal fluid in SD-OCT
timeFrame: at month 12
measure: visual acuity in logmar
timeFrame: at baseline
measure: visual acuity in logmar
timeFrame: at month 1
measure: visual acuity in logmar
timeFrame: at month 2
measure: visual acuity in logmar
timeFrame: at month 3
measure: visual acuity in logmar
timeFrame: at month 4
measure: visual acuity in logmar
timeFrame: at month 5
measure: visual acuity in logmar
timeFrame: at month 6
measure: visual acuity in logmar
timeFrame: at month 7
measure: visual acuity in logmar
timeFrame: at month 8
measure: visual acuity in logmar
timeFrame: at month 9
measure: visual acuity in logmar
timeFrame: at month 10
measure: visual acuity in logmar
timeFrame: at month 11
measure: visual acuity in logmar
timeFrame: at month 12
measure: visual acuity in logmar
timeFrame: at month 13
measure: presence or abscence of hemorrhage, fibrosis and atrophy on fundus color photography
timeFrame: at 1 months
measure: presence or abscence of hemorrhage on fundus color photography
timeFrame: at 1 months
measure: presence or abscence of fibrosis on fundus color photography
timeFrame: at 1 months
measure: presence or abscence of atrophy on fundus color photography
timeFrame: at 1 months
measure: presence or abscence of hemorrhage on fundus color photography
timeFrame: at 13 months
measure: presence or abscence of fibrosis on fundus color photography
timeFrame: at 13 months
measure: presence or abscence of atrophy on fundus color photography
timeFrame: at 13 months
measure: type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions)
timeFrame: Baseline
measure: type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions)
timeFrame: at month 13
measure: type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions)
timeFrame: baseline
measure: type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions)
timeFrame: at month 13
measure: choroidal thickness on EDI-OCT
timeFrame: monthly during 13 months
measure: type of choroidal neovascularization on SD-OCT (type 1, type 2 or mixed lesions)
timeFrame: monthly during 13 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin, CHU de Bordeaux
city: Créteil
country: France
facility: CHI de Créteil
city: Lyon
country: France
facility: Hôpital La Croix Rousse
city: Paris
country: France
facility: Hôpital Lariboisière, APHP
city: Paris
country: France
facility: Centre Ophtalmologique d'Imagerie et de Laser,
Study officials:
References: