AMDCOCTAEylNCT03803631

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

An observational study of AMD and Exudative Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: AMD, Exudative Macular Degeneration
How many people: 49 participants
Where: 5 sitesFrance
Study dates: 4 Apr 2018to 15 Nov 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Show all 10Show fewer

Monitored monthly
Loading phase then bimonthly retreatment.
Signed Informed Consent.
Patient covered by the French Health Insurance

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

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

Other trials in France

About this study

Conditions: AMD, Exudative Macular Degeneration
Medical subject headings: Wet Macular Degeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (168)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 201815 Nov 2021

First posted14 Jan 2019
Study start4 Apr 2018
Primary completion15 Nov 2021
Study completion15 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AMDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03803631
Sponsor's protocol ID: COCTAEyl
Acronym: COCTAEyl
Status last verified: Aug 2025
First submitted: 11 Sep 2018
Last updated: 2 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Amoroso F, Miere A, Kodjikian L, Couturier A, Korobelnik JF, Jung C, Wang X, Blanco-Garavito R, Souied EH. SD-OCT AND OCTA: Distinct or Additional Information on Neovascular Activity? The COCTAEYL Study. Retina. 2026 Jul 1;46(7):1203-1211. doi: 10.1097/IAE.0000000000004815.
PubMed 41759060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
ClinicalTrials.gov ID: NCT03803631
Acronym / sponsor ID: COCTAEyl / COCTAEyl
Conditions: AMD, Exudative Macular Degeneration
Study type: Observational
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
Collaborators: Bayer
Study start: 4 Apr 2018 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 15 Nov 2021 (actual)
First posted: 14 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (10 listed)

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

Key exclusion criteria (17 listed)

Polypoidal choroidal vasculopathy
Type 3 neovascularization
Choroidal neovascularization attributable to causes other than AMD
Macular hematoma
Pigment epithelial detachment higher than 150µm

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

168 secondary outcomes

presence of flow on OCTA
Time frame: baseline
presence of flow on OCTA
Time frame: at month 1
presence of flow on OCTA
Time frame: at month 2
presence of flow on OCTA
Time frame: at month 3
presence of flow on OCTA
Time frame: at month 4
presence of flow on OCTA
Time frame: at month 5
presence of flow on OCTA
Time frame: at month 6
presence of flow on OCTA
Time frame: at month 7
presence of flow on OCTA
Time frame: at month 8
presence of flow on OCTA
Time frame: at month 9
presence of flow on OCTA
Time frame: at month 10
presence of flow on OCTA
Time frame: at month 11
presence of flow on OCTA
Time frame: at month 12
presence of collaterals on OCTA
Time frame: baseline
presence of collaterals on OCTA
Time frame: at month1
presence of collaterals on OCTA
Time frame: at month 2
presence of collaterals on OCTA
Time frame: at month 3
presence of collaterals on OCTA
Time frame: at month 4
presence of collaterals on OCTA
Time frame: at month 5
presence of collaterals on OCTA
Time frame: at month 6
presence of collaterals on OCTA
Time frame: at month 7
presence of collaterals on OCTA
Time frame: at month 8
presence of collaterals on OCTA
Time frame: at month 9
presence of collaterals on OCTA
Time frame: at month 10
presence of collaterals on OCTA
Time frame: at month 11
presence of collaterals on OCTA
Time frame: at month 12
presence of peripheral arcade on OCTA
Time frame: baseline
presence of peripheral arcade on OCTA
Time frame: at month 1
presence of peripheral arcade on OCTA
Time frame: at month 2
presence of peripheral arcade on OCTA
Time frame: at month 3
presence of peripheral arcade on OCTA
Time frame: at month 4
presence of peripheral arcade on OCTA
Time frame: at month 5
presence of peripheral arcade on OCTA
Time frame: at month 6
presence of peripheral arcade on OCTA
Time frame: at month 7
presence of peripheral arcade on OCTA
Time frame: at month 8
presence of peripheral arcade on OCTA
Time frame: at month 9
presence of peripheral arcade on OCTA
Time frame: at month 10
presence of peripheral arcade on OCTA
Time frame: at month 11
presence of peripheral arcade on OCTA
Time frame: at month 12
presence of arteriolization on OCTA
Time frame: at month 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
Derived from this study: PubMed 41759060Amoroso F, Miere A, Kodjikian L, Couturier A, Korobelnik JF, Jung C, Wang X, Blanco-Garavito R, Souied EH. SD-OCT AND OCTA: Distinct or Additional Information on Neovascular Activity? The COCTAEYL Study. Retina. 2026 Jul 1;46(7):1203-1211. doi: 10.1097/IAE.0000000000004815.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of AMD and Exudative Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of flow on OCTA (time frame: at month 13). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03803631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.