Effect of Bevacizumab vs Aflibercept on Visual Acuity Among Patients With Macular Edema Due to Central Retinal Vein Occlusion: The SCORE2 Randomized Clinical Trial

IMPORTANCE: Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data. OBJECTIVE: To investigate whether bevacizumab is noninfe...

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Bibliographic Details
Published in:JAMA : the journal of the American Medical Association 2017-05, Vol.317 (20), p.2072-2087
Main Authors: Scott, Ingrid U, VanVeldhuisen, Paul C, Ip, Michael S, Blodi, Barbara A, Oden, Neal L, Awh, Carl C, Kunimoto, Derek Y, Marcus, Dennis M, Wroblewski, John J, King, Jacqueline
Format: Article
Language:English
Subjects:
Acuity
Age
Aged
Aged, 80 and over
Angiogenesis Inhibitors - adverse effects
Angiogenesis Inhibitors - therapeutic use
Bevacizumab
Bevacizumab - adverse effects
Bevacizumab - therapeutic use
Clinical trials
Criteria
Drug therapy
Drugs
Edema
Endophthalmitis
Eye diseases
Female
Fundus Oculi
Glaucoma
Humans
Immunotherapy
Intraocular pressure
Intravitreal Injections
Macular Edema - drug therapy
Macular Edema - etiology
Male
Middle Aged
Monoclonal antibodies
Occlusion
Off-Label Use
Online First
Original Investigation
Patients
Pressure
Receptors, Vascular Endothelial Growth Factor - therapeutic use
Recombinant Fusion Proteins - therapeutic use
Retina
Retinal Vein Occlusion - complications
Vascular Endothelial Growth Factor A - antagonists & inhibitors
Visual acuity
Visual Acuity - drug effects
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Description
Summary:IMPORTANCE: Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data. OBJECTIVE: To investigate whether bevacizumab is noninferior to aflibercept for the treatment of macular edema secondary to central retinal or hemiretinal vein occlusion. DESIGN, SETTING, AND PARTICIPANTS: The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab. The first participant was randomized on September 17, 2014, and the last month 6 visit occurred on May 6, 2016. Analyses included data available as of December 30, 2016. INTERVENTIONS: Eyes were randomized to receive intravitreal injection of bevacizumab (1.25 mg; n = 182) or aflibercept (2.0 mg; n = 180) every 4 weeks through month 6. MAIN OUTCOMES AND MEASURES: The primary outcome was mean change in visual acuity (VA) letter score (VALS) from the randomization visit to the 6-month follow-up visit, based on the best-corrected electronic Early Treatment Diabetic Retinopathy Study VALS (scores range from 0-100; higher scores indicate better VA). The noninferiority margin was 5 letters, and statistical testing for noninferiority was based on a 1-sided 97.5% confidence interval. RESULTS: Among 362 randomized participants (mean [SD] age, 69 [12] years; 157 [43.4%] women; mean [SD] VALS at baseline, 50.3 [15.2] [approximate Snellen VA 20/100]), 348 (96.1%) completed the month 6 follow-up visit. At month 6, the mean VALS was 69.3 (a mean increase from baseline of 18.6) in the bevacizumab group and 69.3 (a mean increase from baseline of 18.9) in the aflibercept group (model-based estimate of between-group difference, −0.14; 97.5% CI, −3.07 to ∞; P = .001 for noninferiority), meeting criteria for noninferiority. Ocular adverse events in the aflibercept group included 4 participants with intraocular pressure (IOP) more than 10 mm Hg greater than baseline; ocular adverse events in the bevacizumab group included 1 participant with endophthalmitis (culture negative), 9 with IOP more than 10 mm Hg greater than baseline, 2 with IOP higher than 35 mm Hg, and 1 with angle-closure glaucoma not attributed to the study drug or procedure. CONCLUSIO
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2017.4568