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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 Diabetic Retinopathy

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of 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-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 RGX-314 administration in the parent study.

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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

Observational

Primary location

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

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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 RGX-314 for the treatment of DR without CI-DME and must have received an SCS injection of RGX-314 in that study
  • Must be willing and able to comply with all study procedures

Exclusion criteria

  • None

Treatment and study plan

No intervention

Other

All subjects that previously received RGX-314 in a parent study

Primary outcomes

  1. To evaluate the long-term safety of RGX-314

    Time frame: 5 years inclusive of the parent study

    Incidence of overall and ocular adverse events, serious adverse events, and all adverse events of special interest

Secondary outcomes

  1. Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in DR by ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography

    Time frame: 5 years, inclusive of the parent study

  2. Proportion of participants achieving 0-step (no change), a 1-step or greater, a 2-step or greater, or a 3-step or greater improvement in DR per ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography from baseline

    Time frame: 5 years, inclusive to the parent study

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

    Time frame: 5 years, inclusive to the parent study

  4. Proportion of participants gaining or losing ≥5, 10 and 15 letters in BCVA compared with baseline (ie, prior to RGX-314 administration in the parent study)

    Time frame: 5 years, inclusive to the parent study

  5. Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT

    Time frame: 5 years, inclusive to the parent study

  6. Mean change from baseline (ie, prior to 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

  7. 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

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

    Time frame: 5 years, inclusive to the parent study

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

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 Without Center Involved-Diabetic Macular Edema

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 25, 2022
Registry last updated
Jun 18, 2025

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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