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Clinical Trial 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.


Clinical Trial Description

This randomized, partially masked, controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of RGX-314 relative to ranibizumab. Approximately 300 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04704921
Study type Interventional
Source AbbVie
Contact Patient Advocacy
Phone 1-866-860-0117
Email patientadvocacy@regenxbio.com
Status Recruiting
Phase Phase 2/Phase 3
Start date December 29, 2020
Completion date May 2026

See also
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Completed NCT03585556 - AAVCAGsCD59 for the Treatment of Wet AMD Phase 1
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Completed NCT01016873 - INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD Phase 2
Completed NCT03748784 - ADVM-022 Intravitreal Gene Therapy for Wet AMD Phase 1
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Completed NCT04685369 - Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers
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Completed NCT03939767 - Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
Completed NCT03066258 - Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial Phase 1/Phase 2
Terminated NCT01086761 - Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration Phase 1
Recruiting NCT05727397 - Efficacy and Safety of RC28-E Versus Aflibercept Phase 3
Completed NCT04884399 - Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD Phase 1
Completed NCT04964089 - A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) Phase 3
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