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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803631
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Tracking Information
First Submitted Date September 11, 2018
First Posted Date January 14, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date September 4, 2018
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2019)
  • presence of flow on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of collaterals on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of peripheral arcade on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of arteriolization on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of vascular loops on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of dark halo on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of feeder vessel on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • presence of flow void on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular area on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
  • measure of neovascular density on OCTA [ Time Frame: 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 [ Time Frame: at month 13 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at baseline ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 1 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 2 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 3 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 4 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 5 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 6 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 7 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 8 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 9 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 10 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 11 ]
  • Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 12 ]
  • visual acuity in logmar [ Time Frame: at baseline ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 1 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 2 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 3 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 4 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 5 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 6 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 7 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 8 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 9 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 10 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 11 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: at month 12 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS
  • visual acuity in logmar [ Time Frame: 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 [ Time Frame: at 1 months ]
  • presence or abscence of hemorrhage on fundus color photography [ Time Frame: at 1 months ]
  • presence or abscence of fibrosis on fundus color photography [ Time Frame: at 1 months ]
  • presence or abscence of atrophy on fundus color photography [ Time Frame: at 1 months ]
  • presence or abscence of hemorrhage on fundus color photography [ Time Frame: at 13 months ]
  • presence or abscence of fibrosis on fundus color photography [ Time Frame: at 13 months ]
  • presence or abscence of atrophy on fundus color photography [ Time Frame: at 13 months ]
  • type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) [ Time Frame: Baseline ]
  • type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) [ Time Frame: at month 13 ]
  • type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) [ Time Frame: baseline ]
  • type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) [ Time Frame: at month 13 ]
  • choroidal thickness on EDI-OCT [ Time Frame: monthly during 13 months ]
  • type of choroidal neovascularization on SD-OCT (type 1, type 2 or mixed lesions) [ Time Frame: monthly during 13 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
Official Title CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • AMD
  • Exudative Macular Degeneration
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 11, 2019)
49
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Naïve patients
  • Type 1 or type 2 Choroidal NeoVascularization (CNV)
  • Age ≥ 55 years
  • Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
  • At the time of inclusion, multimodal imaging should reveal exudative features
  • Exudative AMD diagnosis established between 1 and 7 days before inclusion
  • Monitored monthly
  • Loading phase then bimonthly retreatment.
  • Signed Informed Consent.
  • Patient covered by the French Health Insurance

Exclusion Criteria:

  • Polypoidal choroidal vasculopathy
  • Type 3 neovascularization
  • Choroidal neovascularization attributable to causes other than AMD
  • Macular hematoma
  • Pigment epithelial detachment higher than 150µm
  • Fibrosis > 50% lesion on fundus color photography, fibroglial scar
  • Media opacity annoying acquisition
  • Retinal vascular occlusion
  • Diabetic retinopathy
  • Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
  • Refractive error >-6D
  • Active intraocular inflammation in the study eye
  • Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
  • Patient taking part in an interventional study at the time of enrolment.
  • Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
  • Pregnant and lactating women
  • Stroke and/or myocardial infarction 3 months before inclusion
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eric SOUIED 01 45 17 50 00 eric.souied@chicreteil.Fr
Contact: Camille JUNG 01 45 17 50 00 camille.jung@chicreteil.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03803631
Other Study ID Numbers COCTAEyl
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Centre Hospitalier Intercommunal Creteil
Study Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators Bayer
Investigators Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date February 2020