A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)

NCT05407636 Phase 3 RECRUITING

ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) 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-vascular endothelial growth factor (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. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

Details

Lead sponsor	AbbVie
Phase	Phase 3
Status	RECRUITING
Enrolment	714
Start date	2022-01-13
Completion	2027-11

Conditions

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

Interventions

• ABBV-RGX-314 Dose 1
• ABBV-RGX-314 Dose 2
• Aflibercept (EYLEA®)

Primary outcomes

• Mean change from baseline in Best Corrected Visual Acuity (BCVA) — At Week 54
  To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
• Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs — Week 50
  AEs and SAEs through Week 50

Countries

United States, Canada, France, Germany, Hungary, Italy, Japan, Puerto Rico, Spain, United Kingdom