Menu
Enrolling by invitation NCT05210803

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

Phase II Interventional Neovascular Age-Related Macular Degeneration (nAMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care, Ranibizumab.
Who it may be relevant to
Registry conditions: Neovascular Age-Related Macular Degeneration (nAMD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration

Overview

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.

Interventions

  • Drug Standard of Care
    Standard of Care
  • Drug Ranibizumab
    Injection

Primary outcome measures

  • Incidences of ocular Adverse Events and any Serious Adverse Events [Time frame: 5 years inclusive of parent study]
Secondary outcome measures (9)
  • Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest [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 [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 [Time frame: 5 years inclusive of parent study]
  • Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5 [Time frame: 5 years inclusive of parent study]
  • Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 [Time frame: 5 years inclusive of parent study]
  • Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 [Time frame: 5 years inclusive of parent study]
  • Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 [Time frame: 5 years inclusive of parent study]
  • Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5 [Time frame: 5 years inclusive of parent study]
  • Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5 [Time frame: 5 years inclusive of parent study]

Eligibility criteria

Inclusion criteria

  • Must provide written, signed informed consent for this study.
  • Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study.
  • Must be willing and able to comply with all study procedures.

Exclusion criteria

1\. None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 16 centers
  • Retinal Research Institute, LLC — Phoenix
  • California Retina Consultants — Bakersfield
  • Retina-Vitreous Associates Medical Group — Beverly Hills
  • Northern California Retina Vitreous Associates Medical Group Inc — Mountain View
  • Retina Consultants San Diego — Poway
  • California Retina Consultants — Santa Barbara
  • Southeast Retina Center PC — Augusta
  • Johns Hopkins University — Baltimore
  • … and 8 more centers

Identifiers

NCT: NCT05210803 · RGX-314-5102 (M23-421) · M23-421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗