A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy

Conditions

Neovascular age-related macular degeneration

Brief summary

Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)

Detailed description

Incidence of non-ocular AEs and any adverse events of special interest (AESIs), Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA, Proportion of participants losing letters in BCVA compared with baseline (ie, prior to ABBV-RGX 314 administration in the parent study) in the study eye at assessed timepoints, Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints, Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of supplemental anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5 based on ongoing chart review, Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5 based on ongoing chart review

Related papers

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Interventions

DRUGSurabgene Lomparvovec (ABBV-RGX-314)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)	—

Secondary

Measure	Time frame
Incidence of non-ocular AEs and any adverse events of special interest (AESIs), Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA, Proportion of participants losing letters in BCVA compared with baseline (ie, prior to ABBV-RGX 314 administration in the parent study) in the study eye at assessed timepoints, Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints, Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of supplemental anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review	—

Measure

Time frame

Incidence of non-ocular AEs and any adverse events of special interest (AESIs), Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA, Proportion of participants losing letters in BCVA compared with baseline (ie, prior to ABBV-RGX 314 administration in the parent study) in the study eye at assessed timepoints, Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints, Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of supplemental anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye, Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review

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Countries

France, Germany, Hungary, Italy, Spain

Outcome results

None listed