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SCORE2 Report 2: Study Design and Baseline Characteristics.

Ingrid U Scott1, Paul C VanVeldhuisen2, Michael S Ip3

  • 1Departments of Ophthalmology and Public Health Sciences, Penn State Eye Center, Penn State College of Medicine, Hershey, Pennsylvania.

Ophthalmology
|November 20, 2016
PubMed
Summary
This summary is machine-generated.

The SCORE2 trial compared intravitreal bevacizumab and aflibercept for retinal vein occlusion. Baseline characteristics were analyzed, revealing a diverse patient population with varying treatment histories.

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Area of Science:

  • Ophthalmology
  • Clinical Trials
  • Retinal Diseases

Background:

  • Retinal vein occlusion (RVO) causes vision loss due to macular edema.
  • Central retinal vein occlusion (CRVO) and hemiretinal vein occlusion (HRVO) are subtypes of RVO.
  • Effective treatments are crucial for managing RVO-induced vision impairment.

Purpose of the Study:

  • To detail the design and baseline characteristics of the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) trial.
  • To compare SCORE2 participants with cohorts from previous RVO trials.
  • To assess intravitreal bevacizumab non-inferiority to intravitreal aflibercept for RVO-related macular edema.

Main Methods:

  • A Phase III, prospective, multicenter, randomized clinical trial.
  • 362 participants (307 with CRVO, 55 with HRVO) were enrolled.
  • Baseline ophthalmic and medical history data were collected.

Main Results:

  • The cohort included diverse demographics and comorbidities like hypertension (77%) and diabetes (31%).
  • Baseline visual acuity averaged 20/100, with mean central subfield thickness of 678 μm.
  • 33% of participants had prior anti-VEGF treatment, with longer macular edema duration.

Conclusions:

  • The SCORE2 cohort is heterogeneous, including CRVO/HRVO and treatment-naïve/pre-treated eyes.
  • Results will have broad applicability for RVO patients with macular edema.
  • Baseline similarities to other trials allow for meaningful cross-trial outcome comparisons.