A Study of Intravitreal REGN2176-3 in Patients with Neovascular ("Wet") Age-Related Macular Degeneration

Overview

About this study

The purpose of this study is to explore the safety and effectiveness of REGN2176-3 on visual acuity in patients with neovascular age-related macular degeneration compared to using intravitreal aflibercept injection monotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Men or women ≥ 50 years of age
  • Active subfoveal choroidal neovascularization secondary to age related macular degeneration as evidenced by Fluorescein angiography in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
  • Best corrected visual acuity on the Early Treatment Diabetic Retinopathy Scale with a letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
  • Provides signed informed consent

 

Exclusion Criteria

  • Any prior treatment with anti-VEGF inhibitors in the study eye
  • Any prior treatment (ie, systemic or ocular treatment) with Platelet derived growth factor or PDGF receptor inhibitors
  • Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
  • Prior vitrectomy in the study eye
  • Any history of macular hole of stage 2 and above in the study eye
  • Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
  • History of corneal transplant in the study eye
  • Evidence of diabetic retinopathy or diabetic macular edema in either eye
  • Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Michael Stewart, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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