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

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03803631

Collaborator

Bayer (Industry)

Enrollment

Locations

56.9

Anticipated Duration (Months)

9.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AMD Exudative Macular Degeneration

Study Design

Study Type:

Observational

Actual Enrollment :

49 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 4, 2018

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

presence of flow on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 13]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

Secondary Outcome Measures

presence of flow on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of collaterals on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of peripheral arcade on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of arteriolization on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of vascular loops on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of dark halo on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of feeder vessel on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
presence of flow void on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular area on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [baseline]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 1]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 2]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 3]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 4]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 5]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 6]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 7]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 8]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 9]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 10]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 11]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
measure of neovascular density on OCTA [at month 12]
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Intraretinal and/or subretinal fluid in SD-OCT [at month 13]
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 [at baseline]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 1]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 2]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 3]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 4]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 5]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 6]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 7]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 8]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 9]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 10]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 11]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 12]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
visual acuity in logmar [at month 13]
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
presence or abscence of hemorrhage, fibrosis and atrophy on fundus color photography [at 1 months]
presence 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Pellegrin, CHU de Bordeaux	Bordeaux	France	33000
2	CHI de Créteil	Créteil	France	94000
3	Hôpital La Croix Rousse	Lyon	France	69004
4	Hôpital Lariboisière, APHP	Paris	France	75010
5	Centre Ophtalmologique d'Imagerie et de Laser,	Paris	France	75015

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil
Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT03803631

Other Study ID Numbers:

COCTAEyl

First Posted:

Jan 14, 2019

Last Update Posted:

Aug 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Wet Macular Degeneration

Study Results

No Results Posted as of Aug 18, 2022