Kathleen Louden

October 25, 2010

October 25, 2010 (Chicago, Illinois) — Patients with neovascular age-related macular degeneration (AMD) who receive monthly intravitreal injections of ranibizumab (Lucentis, Genentech), a vascular endothelial growth-factor (VEGF) antagonist, are likelier to continue driving and to report less difficulty driving than patients who receive sham injections, a new study shows.

The study's lead author, Rohit Varma, MD, MPH, from the Doheny Eye Institute, University of Southern California, Los Angeles, presented the findings as a scientific poster here at the American Academy of Ophthalmology and Middle East Africa Council of Ophthalmology 2010 Joint Meeting.

Patients treated with 0.5 mg of intravitreal ranibizumab believe they drive better than before the treatment, especially at night and in difficult conditions, Dr. Varma told Medscape Medical News.

Previous studies have demonstrated that monthly treatment with ranibizumab improves visual acuity on average. The new study was designed to determine whether this objective improvement translates into self-reported reduced difficulty driving, according to the poster.

Secondary Analysis of MARINA

The researchers performed a secondary analysis of the multicenter Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA). That double-masked phase 3 trial evaluated the safety and efficacy of ranibizumab for patients with choroidal neovascularization. It randomized patients into 3 groups of monthly injections over 24 months.

Of the 712 patients, 237 received sham injections, 236 received 0.3 mg of ranibizumab, and 239 patients received 0.5 mg of ranibizumab.

At baseline and 8 times during treatment, patients completed the National Eye Institute (NEI) 25-item Visual Function Questionnaire (VFQ-25), which includes a driving subscale. The subscale asks whether respondents are still driving and asks them to rate the level of difficulty driving during the daytime in familiar places, driving at night, and driving in difficult conditions, such as bad weather, rush-hour or city traffic, and on the freeway. For each question, subjects responded on a scale ranging from "no difficulty" to "extreme difficulty" and "stopped doing this because of eyesight."

The data showed that 627 of the 712 patients completed the NEI VFQ-25 driving subscale, and 488 (68.6%) reported that they were still driving.

The researchers compared the responses of the 209 patients receiving sham treatment with those of the 212 patients receiving 0.5 mg ranibizumab, which is the dose being marketed. At baseline, the ranibizumab group had a mean VFQ-25 total score of 50.2 (of 100 possible points); the sham group had a slightly higher mean (54.9 points).

Functional Improvement

At 24 months, significantly more ranibizumab-treated than sham-treated patients reported that they were still driving (78.4% vs 67.2%; P = .035, Pearson's χ2 test), according to the poster.

At the same time, those receiving the active drug were significantly more likely to report less difficulty driving at night (33% vs 15.8%; P = .009) and in difficult conditions (40.0% vs 18.3%; P = .001).

Although there were more reports of improved daytime driving in the ranibizumab-treated than in the sham-treated patients (12.1% vs 6.7%), the difference was not statistically significant (P = .203).

"If people have vision loss due to wet AMD, the ophthalmologist should definitely consider this therapy, because it will help patients see better and perform activities [such as driving] better," Dr. Varma said.

The findings did not surprise Julia Haller, MD, ophthalmologist-in-chief at Wills Eye Institute in Philadelphia, Pennsylvania, who enrolled patients in MARINA and saw their vision greatly improve. In an interview, Dr. Haller said that "it makes sense that if your vision is better, your driving is going to be better."

She told Medscape Medical News that the analysis does provide useful information to give to patients considering the injections: that ranibizumab treatment makes a practical difference in function.

"One of the things these patients worry about is their driving. At least in the United States, driving is a big part of independence," Dr. Haller said. "In the past, these patients couldn't be treated and had to stop driving."

Dr. Haller said the new analysis, in which she did not participate, had several strengths, including the fact that its patient population was large, that it was well randomized, and that it used the driving subscale of the "well-validated and widely used" NEI VFQ-25.

Dr. Varma reports receiving grant support and consulting fees from Genentech, and grant support from the National Eye Institute. Dr. Haller reports receiving consulting fees from Genentech in the past, but no longer has a financial relationship with the company.

American Academy of Ophthalmology (AAO) and Middle East Africa Council of Ophthalmology (MEACO) 2010 Joint Meeting: Abstract PO207. Presented October 17, 2010.

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