JAMA Ophthalmology Journal Club Slides:
Visual Function After Ranibizumab
Mitchell P, Bressler N, Tolley K, et al; RESTORE Study Group.
Patient-reported visual function outcomes improve after ranibizumab
treatment in patients with vision impairment due to diabetic macular
edema: randomized clinical trial. JAMA Ophthalmol. Published online
August 22, 2013. doi:10.1001/jamaophthalmol.2013.4592.
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Introduction
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Importance:
– Few data are available on relative changes in vision-related function after
treatment for diabetic macular edema (DME).
– DME is a major cause of visual impairment and can negatively affect patientreported visual function.
– The Ranibizumab Monotherapy or Combined With Laser vs Laser Monotherapy
for Diabetic Macular Edema (RESTORE) trial, a phase 3, randomized, doublemasked, 12-month study at outpatient retina practices in Australia, Canada, and
Europe, showed that ranibizumab therapy (with or without combined laser) was
superior to laser alone for improving best-corrected visual acuity in patients with
visual impairment due to DME.
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Objective:
– To determine the impact of intravitreal ranibizumab, 0.5 mg, compared with
laser alone on patient-reported visual function using the 25-item National Eye
Institute Visual Functioning Questionnaire (NEI VFQ-25) in the RESTORE trial.
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Methods
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Study participants were assigned randomly to ranibizumab plus sham
laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus
laser (n = 111).
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Ranibizumab and sham injections were given for 3 consecutive months
then as needed based on visual acuity; laser and sham laser treatments
were given at baseline then as needed.
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The NEI VFQ-25 was administered at baseline and months 3 and 12.
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The analysis population included all patients receiving 1 or more study
treatments with at least 1 postbaseline NEI VFQ-25 assessment.
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Last observation carried forward (LOCF) was used for missing
postbaseline data.
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Results
VFQ-25 Composite Score: Overall Mean Change From Baseline
(All 25 Questions)
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Results
VFQ-25 General Vision Score: Mean Change From Baseline
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Results
VFQ-25 Near Activities Score: Mean Change From Baseline
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Results
VFQ-25 Distance Activities Score: Mean Change From Baseline
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Results
VFQ-25 Composite Score: Subgroup Analysis by Baseline Visual Acuity
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Results
VFQ-25 Composite Score: Subgroup Analysis by
Baseline Central Retinal Thickness
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Comment
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Vision-related, patient-reported outcomes mirror visual acuity outcomes
and support superiority of ranibizumab or ranibizumab plus laser treatment
over laser monotherapy for patients with DME and characteristics similar to
those enrolled in the RESTORE randomized clinical trial.
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Subscale analyses suggest that improvements in the NEI VFQ-25 score
are most pronounced for the near activities and general vision subscales.
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Contact Information
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If you have questions, please contact the corresponding author:
– Paul Mitchell, MD, PhD, Department of Ophthalmology, The University of Sydney, Eye Clinic,
Westmead Hospital, Hawkesbury Road, Westmead, New South Wales 2145, Australia
(paul.mitchell@sydney.edu.au).
Conflict of Interest Disclosures
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Dr Mitchell reported receiving consultancy fees, lecture fees, and travel support from Novartis
Pharma AG, Pfizer, Solvay (Abbott), Bayer, Alcon, and Allergan. Novartis Pharma AG also funds
a retina fellowship at Westmead Hospital, Sydney, which Dr Mitchell reported serving as
supervisor. Dr Bressler reported serving as principal investigator of grants at The Johns Hopkins
University sponsored by the following entities (not including the National Institutes of Health):
Bayer, Genentech Inc, Lumenis Inc, National Eye Institute, Notal Vision, Novartis Pharma AG,
Optovue, Regeneron Pharmaceuticals Inc, and The EMMES Corporation. Messers Tolley and
Wood reported receiving consultant fees by Novartis Pharma AG to analyze these data. Ms
Gallagher reports being a former employee of Novartis Pharma AG, Basel, Switzerland, and
currently employed by Sanofi, Cambridge, Massachusetts. Drs Petrillo and Ferreira report being
employees of Novartis Pharma AG. Dr Bandello reports serving as an advisory board member for
Alcon, Inc, Alimera Sciences, Inc, Allergan, Inc, Bausch and Lomb, Bayer Schering Pharma,
Farmila-Thea, Genentech, Inc, Hoffmann-LaRoche, Ltd, Pfizer Inc, Novartis Pharmaceuticals
Corporation, sanofi-aventis, and Thrombogenics, Inc.
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