The administration of RGX-314 requires an outpatient surgical procedure performed in an operating room, while the active control, ranibizumab, is administered via intravitreal injection in an office setting. Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More InformationĢ RGX-314 treatment arms, 1 control arm (ranibizumab) Genetic: RGX-314 Biological: Ranibizumab (LUCENTIS®) Condition or diseaseĪMD nAMD Wet Age-related Macular Degeneration wAMD Wet AMD CNV RGX-314 is being developed as a potential one-time treatment for wet AMD. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. 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. 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. Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Why Should I Register and Submit Results?.
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