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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03803631
Other study ID # COCTAEyl
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 4, 2018
Est. completion date July 31, 2023

Study information

Verified date June 2023
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 49
Est. completion date July 31, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France Hôpital Pellegrin, CHU de Bordeaux Bordeaux
France CHI de Créteil Créteil
France Hôpital La Croix Rousse Lyon
France Centre Ophtalmologique d'Imagerie et de Laser, Paris
France Hôpital Lariboisière, APHP Paris

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Bayer

Country where clinical trial is conducted

France, 

Outcome

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