A Phase 2 interventional study of Standard of Care and Ranibizumab in Neovascular Age-Related Macular Degeneration (nAMD), sponsored by AbbVie. Enrolling by invitation at 16 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. None
Dose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration.
Drug: Standard of Care
DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.
Drug: Standard of Care · Drug: Ranibizumab
Standard of Care
Injection
Also known as: LUCENTIS
Incidences of ocular Adverse Events and any Serious Adverse Events
To evaluate the long-term safety of ABBV-RGX-314
Time frame: 5 years inclusive of parent study
Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest
To evaluate the long-term safety of ABBV-RGX-314
Time frame: 5 years inclusive of parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA based on ETDRS score in the study eye at assessed timepoints
To evaluate the persistence of effect of ABBV-RGX-314 on best corrected visual acuity (BCVA)
Time frame: 5 years inclusive of parent study
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
To evaluate the persistence of effect of ABBV-RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)
Time frame: 5 years inclusive of parent study
Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5
To assess the need of clinic visits for management of nAMD
Time frame: 5 years inclusive of parent study
Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5
To assess the need of clinic visits for management of nAMD
Time frame: 5 years inclusive of parent study
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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