Treatment Naive Wet Macular Degeneration

Onyx Study

About The Study:

Principal Investigator: Yevgeniy Shildkrot, MD

Sponsored by Regeneron Pharmaceuticals, the purpose of this study is to compare the efficacy of an investigational drug, REGN910-3, compared to aflibercept in improving best-corrected visual acuity in patients with wet age-related macular degeneration.

All participants will be randomized to one of three study groups:

  • Group A—REGN910-3 (3mg:2mg) administered by intravitreal injection
  • Group B— REGN910-3 (6mg:2mg) administered by intravitreal injection
  • Group C—2mg aflibercept administered by intravitreal injection

Participants participating in this study will make up to 11 scheduled study visits over a period of 36 weeks.  Each visit will last anywhere from 2-5 hours.

Key Inclusion Criteria:

  • Age ≥ 50 years
  • Active subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea
  • BCVA 20/40-20/320 in the study eye

Key Exclusion Criteria:

  • CNV due to any cause other than AMD
  • Prior IVT anti-VEGF in the study eye
  • Evidence of DME or diabetic retinopathy in either eye
  • Any prior treatment with angiopoietin inhibitors
  • Any prior systemic (IV) anti-VEGF administration
  • History of vitreoretinal surgery in the study eye
  • Intraocular pressure ≥ 25 mmHg in the study eye

For additional information about the trials or to refer a patient, contact the study coordinators:

  • Ashton Leone, MPH at (434) 243-5737 or aml7q@virginia.edu
  • Tamika Mercer at (434) 243-2852 or tmm2v@virginia.edu