Driving Ability Reported by Neovascular Age-related Macular Degeneration Patients after Treatment with Ranibizumab

• Published in: Ophthalmology (Rochester, Minn.) Vol. 120; no. 1; pp. 160 - 168
• Main Authors: Bressler, Neil M., MD, Chang, Tom S., MD, Varma, Rohit, MD, Suñer, Ivan, MD, Lee, Paul, MD, Dolan, Chantal M., PhD, Ward, James, PhD, Ianchulev, Tsontcho, MD, MPH, Fine, Jennifer, ScD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 2013
• Subjects: Aged; Aged, 80 and over; Angiogenesis Inhibitors - therapeutic use; Antibodies, Monoclonal, Humanized - therapeutic use; Automobile Driving - statistics & numerical data; Combined Modality Therapy; Double-Blind Method; Female; Humans; Intravitreal Injections; Male; Middle Aged; Ophthalmology; Photochemotherapy; Photosensitizing Agents - therapeutic use; Porphyrins - therapeutic use; Ranibizumab; Self Report; Sickness Impact Profile; Vision, Low - physiopathology; Vision, Low - rehabilitation; Visual Acuity - physiology; Wet Macular Degeneration - drug therapy; Wet Macular Degeneration - physiopathology
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2012.07.027

Objectives To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD). Design Phase III, multicenter, randomized clinical trials (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR]). Participants One thousand one hundred twenty-six patients with choroidal neovascularization resulting from AMD. Methods Participants were assigned randomly to sham (n = 238), 0.3-mg ranibizumab monthly injections (n = 238), or 0.5-mg ranibizumab monthly injections (n = 240) for 24 months (MARINA), or were randomized to verteporfin photodynamic therapy (PDT; n = 143), 0.3-mg ranibizumab monthly injections (n = 140), or 0.5-mg ranibizumab monthly injections (n = 140) for 24 months (ANCHOR). Main Outcome Measures Self-reported driving status and driving ability perception were assessed as exploratory outcomes at baseline through 24 months after baseline using the 25-item National Eye Institute Visual Function Questionnaire. Best-corrected visual acuity in each eye was assessed monthly through 24 months. Results At baseline, 68.6% of patients in the MARINA trial and 62.7% of patients in the ANCHOR trial reported driving. Among patients driving at baseline in the MARINA trial 2 years after randomization, 67.2% (95% confidence interval [CI], 59.2–75.2) of sham patients and 78.4% (95% CI, 71.8–85.0) of 0.5-mg patients reported that they were still driving. Among patients driving at baseline in the ANCHOR trial at 2 years after randomization, 71.6% (95% CI, 60.8–82.4) of PDT patients and 91.4% (95% CI, 85.3–97.5) of 0.5-mg patients were still driving. Also in the ANCHOR trial, ranibizumab-treated patients who were not driving at baseline seemed more likely to drive by months 12 and 24 than PDT patients. Perception of driving ability was correlated with improvement in visual acuity (VA) in the better-seeing eye at 12 and 24 months ( R2 = 0.17 and R2 = 0.20 at 12 and 24 months, respectively [ P <0.001], in the MARINA trial; R2 = 0.13 and R2 = 0.14, respectively [ P <0.001], in the ANCHOR trial). Visual acuity in one or both eyes 2 years after randomization was more likely to be 20/40 or better in the ranibizumab-treated groups. Conclusions These results suggest that patients with neovascular AMD treated with ranibizumab are more likely to report driving ability and have vision of at least 20/40 than patients given sham treatment or PDT. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.