Long-term follow-up of gene therapy RGX-314 in wet macular degeneration
Follows people with wet macular degeneration after a single RGX-314 eye injection.
Plain-language title generated from the registry record
Registry title: Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy
Key facts
- Where
- Créteil, Dijon, Lyon Cedex 04, Marseille, Montauban, Nantes, Nice, Paris, and Toulouse, FranceSee the 9 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people who already received one subretinal injection of RGX-314 in an earlier trial. A small substudy treats the other eye in people with wet macular degeneration in both eyes.
- Age
- 50 years and older. The fellow eye substudy: up to 93 years.
- Sex
- All sexes can join.
- Disease stage
- Main study: none asked beyond earlier RGX-314 treatment. Substudy: active wet age-related macular degeneration (nAMD) in both eyes, with vision between 20 and 80 letters in the fellow eye.
- Earlier treatment
- Must have received a single subretinal administration of RGX-314 in an earlier clinical study.
Main reasons for not taking part
- Substudy: new vessel growth or fluid in the fellow eye from a cause other than wet macular degeneration
- Substudy: scarring or wasting under the centre of the retina in the fellow eye
- Substudy: advanced glaucoma, past secondary glaucoma, or surgery to treat glaucoma
- Substudy: heart attack, stroke or mini-stroke within the past 6 months
- Substudy: eye surgery in the fellow eye within 12 weeks of screening
Read by machine on 12 November 2026.
Where in France
- Centre Hospitalier Intercommunal CréteilCréteil, FranceNot yet recruiting
- Centre Hospitalier Universitaire de DijonDijon, FranceNot yet recruiting
- Hospices Civils De LyonLyon Cedex 04, FranceNot yet recruiting
- Centre Monticelli Paradis d'OphtalmologieMarseille, FranceNot yet recruiting
- Clinique Honoré CaveMontauban, FranceNot yet recruiting
- Centre Hospitalier Universitaire de NantesNantes, FranceNot yet recruiting
- Centre Hospitalier Universitaire de NiceNice, FranceNot yet recruiting
- Assistance Publique Hopitaux de ParisParis, FranceNot yet recruiting
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AbbVie
- Trial code
- NCT03999801EU 2023-505750-17-00
- Record updated
- 17 June 2024
- Original description
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 in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period.Read full original descriptionShow less
A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants With Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy
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 in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period.
Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.
Inclusion: Able and willing to provide written consent; Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314; Exclusions Criteria:; None; Fellow Eye Substudy:; Age ≤ 93 years; Currently or previously enrolled in the main observational study; Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration; Active nAMD in the fellow eye; BCVA between ≤ 80 and ≥ 20 letters in the fellow eye.
Exclusion: History of intravitreal therapy, such as intravitreal steroid injection or investigational product, other than an intravitreal therapy for nAMD, in the fellow eye within 6 months of screening; Advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma; Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months; History of intraocular surgery in the fellow eye within 12 weeks of screening; CNV or macular edema in the fellow eye secondary to causes other than nAMD; Subfoveal fibrosis or atrophy in the fellow eye.
Main Observational Study:.