Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)

Conditions

• Central Retinal Vein Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• aflibercept — DRUG
• bevacizumab — DRUG

Study Details

SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every 4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at Month 6.

Key Dates

Start date

Sep 30, 2014

Status verified

Jun 2021

Primary completion

Nov 30, 2016

Completion

Mar 31, 2021

Study Design

Enrollment

362 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: aflibercept
  2.0 mg aflibercept every 4 weeks
• Active Comparator: bevacizumab
  1.25 mg bevacizumab every 4 weeks

Primary Outcome Measure

Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 [ Time Frame: Month 0 to 6 ]

Locations (72)

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