Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
NCT04704921
AMD, CNV
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT03803631
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.
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Notify Me55 year and older
All sexes
Observational
Hôpital Pellegrin, CHU de Bordeaux, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: baseline
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 1
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 2
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 3
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 4
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 5
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 6
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 7
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 8
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 9
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 10
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 11
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 12
high flow on OCTA corresponding to the neovascular network with vascular remodeling over time
Time frame: at month 13
Time frame: at baseline
Time frame: at month 1
Time frame: at month 2
Time frame: at month 3
Time frame: at month 4
Time frame: at month 5
Time frame: at month 6
Time frame: at month 7
Time frame: at month 8
Time frame: at month 9
Time frame: at month 10
Time frame: at month 11
Time frame: at month 12
Time frame: at baseline
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 1
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 2
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 3
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 4
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 5
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 6
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 7
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 8
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 9
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 10
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 11
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 12
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at month 13
Measure of best-corrected visual acuity (BCVA) measured on ETDRS
Time frame: at 1 months
Time frame: at 1 months
Time frame: at 1 months
Time frame: at 1 months
Time frame: at 13 months
Time frame: at 13 months
Time frame: at 13 months
Time frame: Baseline
Time frame: at month 13
Time frame: baseline
Time frame: at month 13
Time frame: monthly during 13 months
Time frame: monthly during 13 months
Centre Hospitalier Intercommunal Creteil
Other
Acronym: COCTAEyl
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