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Original Investigation |

Effect of Ranibizumab on the Decision to Drive and Vision Function Relevant to Driving in Patients With Diabetic Macular Edema Report From RESTORE, RIDE, and RISE Trials

Neil M. Bressler, MD1,2; Rohit Varma, MD3; Paul Mitchell, MD4; Ivan J. Suñer, MD5; Chantal Dolan, PhD6; James Ward, PhD7; Alberto Ferreira, PhD, MBA8; Jason S. Ehrlich, MD, PhD7; Adam Turpcu, PhD7
[+] Author Affiliations
1Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland
2Editor, JAMA Ophthalmology
3University of Southern California Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles
4University of Sydney, Sydney, New South Wales, Australia
5Retina Associates of Florida, Tampa
6CMD Consulting, Sandy, Utah
7Genentech Inc, South San Francisco, California
8Novartis Pharma AG, Basel, Switzerland
JAMA Ophthalmol. 2016;134(2):160-166. doi:10.1001/jamaophthalmol.2015.4636.
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Importance  The potential effect of treatments for diabetic macular edema (DME) on driving should be of value to patients and clinicians, such as ophthalmologists and other physicians, who treat patients with diabetes mellitus.

Objective  To determine the effect of ranibizumab on driving and patient-reported vision function relevant to driving among patients with DME.

Design, Setting, and Participants  This exploratory post hoc analysis was conducted between October 1, 2011, and July 25, 2015, based on deidentified data from phase 3, multicenter, randomized clinical trials (RIDE, RISE, and RESTORE trials). Individuals assigned randomly to monthly sham, 0.3-mg ranibizumab, or 0.5-mg ranibizumab in RIDE and RISE or to macular laser, macular laser plus 0.5-mg ranibizumab (3-monthly doses, then as needed), or 0.5-mg (3-monthly doses, then as needed) in RESTORE.

Main Outcomes and Measures  Driving items from the National Eye Institute (NEI) Visual Function Questionnaire–25 (VFQ-25) at baseline through 24 months in RIDE/RISE (pooled) and through 12 months in RESTORE.

Results  A total of 71.2% of 753 patients in RIDE/RISE and 50.4% of 345 patients in RESTORE reported driving at baseline; at least 55% reported still driving at follow-up. Among those not driving at baseline in RIDE/RISE, at 12 months, 7.0% (95% CI, −5.0 to 19.0) more in the 0.3-mg group and 14.4% (95% CI, 1.1 to 27.7) more in the 0.5-mg group vs the sham group reported driving. Among those not driving at baseline in RESTORE, at 12 months, 4.2% (95% CI, −7.7 to 16.1) more in the laser plus 0.5-mg group and 0.9% (95% CI, −10.3 to 12.1) more in the 0.5-mg group vs the laser group reported driving. Although balanced at baseline across treatment groups for RESTORE and RIDE/RISE, the proportion of patients with best-corrected visual acuity typically required for an unrestricted license (20/40 or better in at least 1 eye) appeared greater at month 12 in the ranibizumab groups (77 of 80 [96.3%] for 0.5 mg + laser and 91 of 93 [97.8%] for 0.5 mg) vs laser (71 of 79 [89.9%]) in RESTORE, and at months 12 (112 of 123 [91.1%] and 136 of 137 [99.3%] in 0.3- and 0.5-mg groups, respectively) and 24 (113 of 123 [91.9%] and 135 of 137 [98.5%] in the 0.3- and 0.5-mg groups, respectively) vs sham (121 of 147 [82.3%] and 122 of 147 [83.0%]) in RIDE/RISE.

Conclusions and Relevance  These results suggest that 12 months after initiating ranibizumab for vision impairment from center-involved DME, patients not driving at initiation of treatment are more likely to report driving and have driving-eligible visual acuity of 20/40 or better in the better-seeing eye than those treated with sham or laser.

Trial Registration  clinicaltrials.gov Identifier: RESTORE: NCT00687804; RIDE: NCT00473382; and RISE: NCT00473330

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Figure.
Mean Changes From Baseline in National Eye Institute (NEI) Visual Function Questionnaire (VFQ)–25 Driving Subscale Scores for (A) 12 Months (RIDE, RISE, and RESTORE) and (B) 24 Months (RIDE and RISE only)

RISE and RIDE indicate Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus; RESTORE, 12-Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study.

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