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Gene Therapy

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

Phase 2
Waitlist Available
Research Sponsored by REGENXBIO, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≤ 93 years
Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years inclusive of parent study
Awards & highlights

RGX-314 SRLTFU Trial Summary

This trial will evaluate the safety & efficacy of RGX-314 over 5yrs in people who have received it in one eye in a previous study. A substudy will look at its safety & immunogenicity in the fellow eye.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects aren't listed here, but generally, treatments like RGX-314 could cause irritation at the injection site, changes in vision, eye discomfort or possible immune reactions.

RGX-314 SRLTFU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 93 years old or younger.
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I have been diagnosed with a specific eye condition due to aging.
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I was in a RGX-314 study and got the treatment once.
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My other eye is affected by wet age-related macular degeneration.

RGX-314 SRLTFU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years inclusive of parent study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years inclusive of parent study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fellow eye substudy: Incidence of ocular adverse events and any serious adverse events in the fellow eye
Incidence of ocular adverse events and any serious adverse events in the study eye
Secondary outcome measures
Change from baseline in Central Retinal Thickness (CRT) in the study eye
Change from baseline in best corrected visual acuity (BCVA) in the study eye
Fellow eye substudy: Aqueous and Serum RGX-314 transgene product (TP) concentrations in the fellow eye
+6 more

Side effects data

From 2021 Phase 1 & 2 trial • 42 Patients • NCT03066258
67%
Retinal Haemorrhage
67%
Intraocular Inflammation
50%
Visual Acuity Reduced/Impairment
33%
Conjunctival Haemorrhage
33%
Photopsia
17%
Pneumonia
17%
Eye Pain
17%
Hypervolaemia
17%
Arthritis
17%
Respiratory Failure
17%
Intraocular Pressure Increased
17%
Vision Blurred
17%
Dry Age-Related Macular Degeneration
17%
Photophobia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 4
Cohort 2
Cohort 3
Cohort 5

RGX-314 SRLTFU Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGX-314
2021
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
1,428 Total Patients Enrolled
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
1,428 Total Patients Enrolled
AbbVieLead Sponsor
954 Previous Clinical Trials
500,240 Total Patients Enrolled

Media Library

RGX-314 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03999801 — Phase 2
Age-Related Macular Degeneration Research Study Groups: RGX-314 Fellow Eye Treatment Substudy, Main Observational Study
Age-Related Macular Degeneration Clinical Trial 2023: RGX-314 Highlights & Side Effects. Trial Name: NCT03999801 — Phase 2
RGX-314 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999801 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks do participants in the RGX-314 Fellow Eye Treatment Substudy face?

"As this is a Phase 2 clinical trial, there is some evidence that RGX-314 Fellow Eye Treatment Substudy is safe but no data to suggest its efficacy. Hence it received an appraisal of two out of three on our internal rating system at Power."

Answered by AI

How extensively is this trial being implemented across the nation?

"Presently, this clinical trial is operating at 17 total sites. Major cities such as Santa Barbara, Baltimore and Boston all have active locations along with fourteen other centres. To better minimise the amount of travel required for participants in the study, it is important to locate the nearest site available to you."

Answered by AI

Are new participants being added to this clinical experiment?

"Per clinicaltrials.gov, this trial has ended its recruitment and is no longer accepting subjects for participation. The initial posting date was May 31st 2019 and the last update occured on March 29th 2023. Nevertheless, there are currently 169 other trials that need candidates to join in their research endeavours."

Answered by AI

What objectives is this clinical trial attempting to accomplish?

"As reported by AbbVie, the primary endpoint for this trial will be the Fellow eye substudy: Incidence of ocular adverse events and any serious adverse events in the fellow eye over a 5 year period. Additionally, secondary endpoints including Change from baseline in best corrected visual acuity (BCVA) as measured by Mean change and proportion of participants losing greater than or equal to 5, 10, and 15 letters; Change from baseline in Central Retinal Thickness (CRT) per SD-OCT imaging technology; and Number of supplemental anti-VEGF injections based on chart review are being evaluated."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy
2019. "Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999801.
All > Age Related Macular Degeneration > Wet Macular Degeneration
~417 spots leftby Dec 2028
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