Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Conditions

• AMD
• CNV
• Choroidal Neovascularization
• Neovascular AMD
• Neovascular Age-related Macular Degeneration
• Wet AMD
• Wet Age-related Macular Degeneration
• nAMD
• wAMD

Eligibility Criteria

Sex

ALL

Age

50 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• ABBV-RGX-314 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
• ABBV-RGX-314 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
• Ranibizumab (LUCENTIS®) — BIOLOGICAL
  0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days

Study Details

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). 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 (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Key Dates

Start date

Dec 29, 2020

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Nov 30, 2027

Study Design

Enrollment

671 participants (actual)

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
  Ranibizumab administered via intravitreal injection approximately every 28 days

Primary Outcome Measure

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

Locations (89)

Find similar trials in Phoenix, AZ

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