By Cameron Johnston
FORT LAUDERDALE, FL -- May 14, 2007 -- Significantly more patients with neovascular age-related macular degeneration gain vision after 24 months of treatment with ranibizumab (Lucentis) as compared with those who are treated with verteporfin-based photodynamic therapy alone, researchers reported here at the meeting of the Association for Research in Vision and Ophthalmology (ARVO).
Patients treated with Lucentis also showed substantial improvements in their ability to perform many activities of daily living. As a result, their overall quality of life was improved as well.
The data were part of an ongoing study in which patients were treated with either Lucentis 0.3 mg or 0.5 mg monthly or photodynamic therapy (PDT) every three months over a two-year period.
There were 140 patients in each Lucentis arm and 143 patients in the PDT arm. Patients averaged 76 to 77 years of age and visual acuity at enrolment ranged from 20/40 to 20/320. Both the patients and the investigators were masked as to who received which treatment.
Subjects were asked to complete the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at months 1, 2, 3, 6, 9, 12, 18 and 24. The 15-page questionnaire consists of 12 domains, or subscales where the patient's answers were scored from 0 to 100, with a positive difference indicating an improvement in functioning. Most of the questions concerned the patient's subjective feelings and their abilities to perform activities of daily living.
A change of 5 to 10 points on any one subscale was deemed to be equivalent to a three-line change in visual acuity and was considered to be clinically meaningful.
After 24 months, patients in both Lucentis arms showed more or less identical improvements in the near and distance subscales. Patients who were treated with PDT, however, showed declining scores on each scale. The mean differences between the Lucentis and PDT arms were 6.9 points on the near activity subscale, 7.4 points on the distance activity subscale, and 8.4 points on the dependency subscale. The differences in distance activity scores and dependency scores were considered to be statistically significant. The difference in near activity scores was not significant.
Differences were seen in all other subscales including general vision, vision-specific social functioning, vision-specific mental health and driving, all of which were superior in the Lucentis arms compared with the PDT arm at 12 and 24 months.
While PDT may have slowed the progress of macular degeneration and the loss of visual function in many of these subjects, most of the patients in the Lucentis arms reported improvements in visual functioning. Moreover, the decrease in visual functioning in the PDT arm was pronounced enough that beginning at month 18, patients began crossing over to the Lucentis 0.3 mg arm. In all, 50 out of 143 patients made the change from PDT treatment to Lucentis treatment.
The authors of the study, headed by Dr. Stephen G. Schwartz, assistant professor of clinical ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, Florida, United States, said the improvements seen in this trial were consistent with and added to data that has been seen in other Lucentis studies.
The data show that the improvement seen with Lucentis therapy was not just a physiological change but also translated into meaningful improvements in quality of life and activities of daily living.
The study was funded by Genentech Inc.
[Presentation title: Patient-Reported Visual Function Over 24 Months in Predominantly Classic Neovascular AMD: Results From ANCHOR, a Phase III Trial of Ranibizumab and Verteporfin PDT. Poster 1882 -- B682]
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