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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: AMD; Exudative Macular Degeneration

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hôpital Pellegrin, CHU de Bordeaux
  • Créteil, France, 94000
    • CHI de Créteil
  • Lyon, France, 69004
    • Hôpital La Croix Rousse
  • Paris, France, 75010
    • Hôpital Lariboisière, APHP
  • Paris, France, 75015
    • Centre Ophtalmologique d'Imagerie et de Laser,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): January 15, 2023
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: COCTAEyl

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No