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NCT05296447Enrolling by invitationPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
16 Mar 2022
Start date
4 Apr 2022
Primary completion date
Jun 2031
Lead sponsor
AbbVie
NCT number
NCT05296447

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • From 4 Apr 2022 to the primary completion date, Jun 2031
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vision Research Center Eye Associates of New Mexico
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Southeast Retina Center, PC
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status
Austin Clinical Research
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
California Retina Consultants
Coordinator of this site? Confirm its status
BakersfieldUnited StatesUnknown status
Retina-Vitreous Associates Medical Group
Coordinator of this site? Confirm its status
Beverly HillsUnited StatesUnknown status
Ophthalmic Consultants of Boston
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Charles Retina Institute, P.C
Coordinator of this site? Confirm its status
GermantownUnited StatesUnknown status
Cumberland Valley Retina Consultants
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Retinal Diagnostic Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Northern California Retina Vitreous Associates Medical Group INC.
Coordinator of this site? Confirm its status
Mountain ViewUnited StatesUnknown status
University Retina and Macula Associates, PC
Coordinator of this site? Confirm its status
Oak ForestUnited StatesUnknown status
California Eye Specialists Medical Group, Inc.
Coordinator of this site? Confirm its status
PasadenaUnited StatesUnknown status
Mid Atlantic Retina
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Retinal Research Institute, LLC
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Retina Consultants San Diego
Coordinator of this site? Confirm its status
PowayUnited StatesUnknown status
Sierra Eye Associates
Coordinator of this site? Confirm its status
RenoUnited StatesUnknown status
California Retina Consultants CRC
Coordinator of this site? Confirm its status
Santa BarbaraUnited StatesUnknown status
New Jersey Retina
Coordinator of this site? Confirm its status
TeaneckUnited StatesUnknown status
Retina Consultants of Texas
Coordinator of this site? Confirm its status
The WoodlandsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.