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

August 3, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Research Institute, LLC
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Los Angeles, California, United States, 90017
        • Retinal Diagnostic Center
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group Inc
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group, Inc
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants CRC
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center, PC
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, PC
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • New Jersey Retina
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center Eye Associates of New Mexico
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute, P.C
    • Texas
      • Austin, Texas, United States, 78750
        • Austin Clinical Research
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Study population includes participants who received RGX-314 in a parent study of DR without center involved-diabetic macular edema

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Standard of Care
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.
Drug: Standard of Care
Standard of Care
Other: Supplemental Treatment
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.
Drug: Standard of Care
Standard of Care
Drug: Aflibercept
Injection
Other Names:
  • EYLEA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
5 years inclusive of the parent study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
5 years, inclusive to the parent study
Proportion of participants with any sight-threatening ocular diabetic complications
Time Frame: 5 years, inclusive to the parent study
5 years, inclusive to the parent study
Incidences of non-ocular AEs and any Adverse Events of Special Interest
Time Frame: 5 years, inclusive to the parent study
5 years, inclusive to the parent study
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
5 years, inclusive of the parent study
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
5 years, inclusive to the parent study
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 years, inclusive to the parent study
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
5 years, inclusive to the parent study
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
5 years, inclusive to the parent study
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
5 years, inclusive to the parent study
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
5 years, inclusive to the parent study
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
5 years, inclusive to the parent study
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
5 years, inclusive to the parent study
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
5 years, inclusive to the parent study
Mean number of retina specialist visits attended for complications of DR based on chart review
Time Frame: 5 years, inclusive to the parent study
5 years, inclusive to the parent study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
REGENXBIO Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGX-314-5201 (M23-420)
  • M23-420 (Other Identifier: AbbVie Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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