SCORE2

Clinical Trials // Macular Edema // Michael Altaweel // Ongoing // Retinal Vein Occlusion // Sep 30 2020

A Multicenter, Prospective, Randomized Non-Inferiority Trial of Eyes with Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing Intravitreal Bevacizumab Every 4 Weeks with Intravitreal Aflibercept Every 4 Weeks

  • Sponsor: The Emmes Company, LLC
  • Principal Investigator: Michael Altaweel, MD
  • Study Coordinator: Angie Adler

Study objective:

To determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with central retinal vein occlusion (CRVO).

Study design:

The subject will be randomized to receive intravitreal bevacizumab every 4 weeks or intravitreal aflibercept every 4 weeks. Study duration is approximately 2.5 years.

Inclusion criteria:

  • E-Early Treatment Diabetic Retinopathy Study (ETDRS)visual acuity score of greater than or equal to 19 letters (approximately 20/400) and less than or equal to 73 letters (approximately 20/40) by the ETDRS visual acuity protocol
  • Retinal thickness on SD-OCT measurement, defined as central subfield thickness of 300 µm or greater. If the SD-OCT measurement is taken from a Heidelberg Spectralis Machine, the central subfield thickness should be 320 µm or greater

Exclusion criteria:

  • Examination evidence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT thought to be contributing to macular edema
  • Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract)
  • History of laser photocoagulation for macular edema within 3 months prior to randomization
  • History of intravitreal corticosteroid within 4 months of randomization
  • Intravitreal anti-VEGF injection within 2 months of randomization
  • History of peribulbar or retrobulbar corticosteroid use for any reason within 2 months prior to randomization
  • History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization
  • Aphakia
  • Presence of an anterior chamber intraocular lens
  • Examination evidence of external ocular infection, including conjunctivitis, chalazion or significant blepharitis
  • History of macular detachment
  • Examination evidence of any diabetic retinopathy

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.gov