Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

Conditions

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

Eligibility Criteria

Sex

ALL

Age

50 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• ABBV-RGX-314 Dose 1 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
• ABBV-RGX-314 Dose 2 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
• Aflibercept (EYLEA®) — BIOLOGICAL
  2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections

Study Details

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.

Key Dates

Start date

Jan 13, 2022

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Nov 30, 2027

Study Design

Enrollment

714 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ABBV-RGX-314 Dose 1
  ABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
• Experimental: ABBV-RGX-314 Dose 2
  ABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
• Active Comparator: Control Arm
  Aflibercept administered via intravitreal injection approximately every 8 weeks

Primary Outcome Measure

Mean change from baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: At Week 54 ]

Central Contacts

• Patient Advocacy
  1-833-711-0349
  [email protected]

Locations (107)

Find similar trials in Phoenix, AZ

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