Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

Enrolling by invitation · Phase 2

Conditions studied: Neovascular Age-related Macular Degeneration, Wet Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03999801

Run by

AbbVie

People needed

865

Starts

2019-05-31

Expected to finish

2028-12-01

Last updated by the study team

2024-06-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Inclusion Criteria
• 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

You may not qualify if…

• CNV or macular edema in the fellow eye secondary to causes other than nAMD
• Subfoveal fibrosis or atrophy in the fellow eye
• 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
• 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

Where it is running

• Retinal Research Institute, LCC — Phoenix, Arizona, United States
• California Retina Consultants CRC — Santa Barbara, California, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Sierra Eye Associates — Reno, Nevada, United States
• University of Pennsylvania Department of Ophthalmology — Philadelphia, Pennsylvania, United States
• MidAtlantic Retina — Philadelphia, Pennsylvania, United States
• Charles Retina Institute — Germantown, Tennessee, United States
• Retina Consultants of Texas Research Center — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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