RGX-314 Dose 2 for AMD

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Santa Ana Location, Santa Ana, CA
AMD+6 More
RGX-314 Dose 2 - Genetic
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD.

Eligible Conditions

  • AMD
  • CNV
  • wAMD
  • WetAMD
  • Wet Age-related Macular Degeneration
  • nAMD

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: At Week 14, Week 38, Week 54, Week 74 and Week 90

Week 90
Aqueous RGX-314 TP concentrations
At Week 54
Incidences of ocular and overall Serious Adverse Events (SAEs)
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Week 54
Mean change from baseline in BCVA
Week 90
Mean change from baseline in CRT and CPT as measured by SD-OCT
Week 90
Mean reduction in supplemental anti VEGF injection annualized rate compared with the prior year of therapy
Mean supplemental anti VEGF injection annualized rate in the RGX-314 arms

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Control Arm
1 of 3
RGX-314 Dose 2
1 of 3
RGX-314 Dose 1
1 of 3
Active Control
Experimental Treatment

465 Total Participants · 3 Treatment Groups

Primary Treatment: RGX-314 Dose 2 · No Placebo Group · Phase 3

RGX-314 Dose 2
Genetic
Experimental Group · 1 Intervention: RGX-314 Dose 2 · Intervention Types: Genetic
RGX-314 Dose 1
Genetic
Experimental Group · 1 Intervention: RGX-314 Dose 1 · Intervention Types: Genetic
Control Arm
Biological
ActiveComparator Group · 1 Intervention: Aflibercept (EYLEA®) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 14, week 38, week 54, week 74 and week 90
Closest Location: Santa Ana Location · Santa Ana, CA
N/AFirst Recorded Clinical Trial
2 TrialsResearching AMD
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to provide written, signed informed consent for this study.
You must have demonstrated a meaningful response to anti-VEGF therapy at study entry.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.