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NCT05296447

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy

StatusActive, Not Recruiting
PhasePhase 2
SponsorAbbVie
Primary completion (estimated)
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Record History

All 8 versions: 6 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 4 words
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 103
  2. Primary and study completion pushed from May 2028 to Jun 2031v7 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Not specified → Phase 2
    • Eligibility criteria expanded, about 2 words
    • Trial arms changed: 1 → 2
    • Study sites: 19 to 20
    • Interventions: No Intervention (Other) to Aflibercept (Drug), Standard of Care (Drug)
    • Secondary endpoints: 8 to 14
    • Collaborators expanded, about 2 words
    • Study title expanded, about 2 words
  3. Lead sponsor: REGENXBIO Inc. to AbbVie
    • Collaborators shortened, about 1 word
    v4
  4. Enrollment target: 60 to 100
    • Study sites: 18 to 19
    • Primary and study completion dates: Feb 2028 to May 2028
    • Collaborators expanded, about 1 word
    v3
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Mar 2022 to Apr 4, 2022
    v2
  6. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)
Timeframe: 5 years inclusive of the parent study

Secondary (14)

Incidences of non-ocular AEs and any Adverse Events of Special Interest
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography
Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA
Proportion of participants gaining or losing ≥ 5, 10, and 15 letters in BCVA compared with baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
Show 9 moreShow less
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA
Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)
Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)
Proportion of participants with any sight-threatening ocular diabetic complications
Mean number of retina specialist visits attended for complications of DR based on chart review

Arms and interventions

Standard of CareOther

Dose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration.

Supplemental TreatmentOther

DL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye.

Drugs: Standard of Care, Aflibercept

Sites

20 sites in 1 country