Copyright restrictions may apply JAMA Ophthalmology Journal Club Slides: Visual Function After Ranibizumab Mitchell P, Bressler N, Tolley K, et al; RESTORE

Copyright restrictions may apply

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.


Introduction

• 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 patient-

reported visual function.– The Ranibizumab Monotherapy or Combined With Laser vs Laser Monotherapy

for Diabetic Macular Edema (RESTORE) trial, a phase 3, randomized, double-masked, 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.

• 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.


• Study participants were assigned randomly to ranibizumab plus sham laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus laser (n = 111).

• 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.

• The NEI VFQ-25 was administered at baseline and months 3 and 12.

• The analysis population included all patients receiving 1 or more study treatments with at least 1 postbaseline NEI VFQ-25 assessment.

• Last observation carried forward (LOCF) was used for missing postbaseline data.

Methods


ResultsVFQ-25 Composite Score: Overall Mean Change From Baseline

(All 25 Questions)


Results

VFQ-25 General Vision Score: Mean Change From Baseline


Results

VFQ-25 Near Activities Score: Mean Change From Baseline


Results

VFQ-25 Distance Activities Score: Mean Change From Baseline


Results

VFQ-25 Composite Score: Subgroup Analysis by Baseline Visual Acuity


Results

VFQ-25 Composite Score: Subgroup Analysis by Baseline Central Retinal Thickness


• 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.

• Subscale analyses suggest that improvements in the NEI VFQ-25 score are most pronounced for the near activities and general vision subscales.

Comment


• 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 ([email protected]).

Conflict of Interest Disclosures• 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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Copyright restrictions may apply JAMA Ophthalmology Journal Club Slides: Visual Function After Ranibizumab Mitchell P, Bressler N, Tolley K, et al; RESTORE