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Enrolling by invitation

NCT Number: NCT05296447

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

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 DR with and without center involved-diabetic macular edema (CI-DME) 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 a total of 5 years post-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.

Enrolling by invitation

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Key information

Conditions

Diabetic Retinopathy, DR Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Research Institute, LLC, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must provide written, signed informed consent for this study
  • Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME 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

  • None

Treatment and study plan

Standard of care

Drug

Standard of Care

aflibercept

Drug

Injection

Other names: EYLEA

Primary outcomes

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

    Time frame: 5 years inclusive of the parent study

    To evaluate the long-term safety of ABBV-RGX-314

Secondary outcomes

  1. Incidences of non-ocular AEs and any Adverse Events of Special Interest

    Time frame: 5 years, inclusive to the parent study

  2. 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

    Time frame: 5 years, inclusive of the parent study

  3. 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)

    Time frame: 5 years, inclusive to the parent study

  4. Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA

    Time frame: 5 years, inclusive to the parent study

  5. 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)

    Time frame: 5 years, inclusive to the parent study

  6. Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT

    Time frame: 5 years, inclusive to the parent study

  7. 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

    Time frame: 5 years, inclusive to the parent study

  8. Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)

    Time frame: 5 years, inclusive to the parent study

  9. 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)

    Time frame: 5 years, inclusive to the parent study

  10. 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)

    Time frame: 5 years, inclusive to the parent study

  11. 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)

    Time frame: 5 years, inclusive to the parent study

  12. 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)

    Time frame: 5 years, inclusive to the parent study

  13. Proportion of participants with any sight-threatening ocular diabetic complications

    Time frame: 5 years, inclusive to the parent study

  14. Mean number of retina specialist visits attended for complications of DR based on chart review

    Time frame: 5 years, inclusive to the parent study

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • REGENXBIO Inc.

Registry information

Official study title

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Mar 25, 2022
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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