RGX-314 for Age-Related Macular Degeneration
(RGX-314 SRLTFU Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: REGENXBIO, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people up to 93 years old with a condition called age-related macular degeneration (AMD) in both eyes. They must have previously received RGX-314 treatment in one eye and be willing to consent. The study excludes those who don't meet the vision criteria or haven't been part of the main observational study.

Inclusion Criteria

BCVA between ≤ 80 and ≥ 20 letters in the fellow eye

I am 93 years old or younger.

I have been diagnosed with a specific eye condition due to aging.

+5 more

Participant Groups

The long-term effects and safety of RGX-314 are being studied over five years in patients who've had it before. A subgroup will also get RGX-314 in their other eye, which hasn't been treated yet, to see how well it works there.

2Treatment groups

Experimental Treatment

Active Control

Group I: RGX-314 Fellow Eye Treatment SubstudyExperimental Treatment1 Intervention

RGX-314 Fellow Eye Treatment

Group II: Main Observational StudyActive Control1 Intervention

All subjects that previously received RGX-314 in a subretinal administration parent study are enrolled into this arm.