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P. J. Rosenfeld, H. Shapiro, N. Shams, S. Schneider, E. E. Depperschmidt, MARINA and ANCHOR Study Groups; Baseline and Treatment Characteristics of Patients Losing Vision at Year 1 of the MARINA and ANCHOR Trials. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4576.
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Monthly injections of 0.3 mg or 0.5 mg ranibizumab (LucentisTM, Genentech) in Genentech’s Phase III MARINA and ANCHOR trials resulted in mean visual acuity improvement with 25% to 40% of these neovascular AMD patients gaining at least 15 letters of visual acuity. However, some patients do experience vision loss at 1 year after monthly injections of ranibizumab and the loss of at least 15 letters of visual acuity (moderate vision loss) would be considered a treatment failure. To investigate the cause of vision loss in these patients, we reviewed the baseline and treatment characteristics of patients who experienced at least moderate vision loss at 1 year.
Subjects experiencing at least moderate vision loss and moderate vision gain in the MARINA and ANCHOR trials were identified. From patients who experienced vision loss, baseline patient characteristics of gender, age, prior therapy, visual acuity, lesion type, lesion size, area of leakage, and presence of hemorrhage will be identified and compared with the same baseline characteristics in patients who experienced at least moderate vision improvement. Similarly, at 1 year, lesion characteristics including lesion size, area of leakage, and presence of retinal pigment epithelial tears, hemorrhage, and geographic atrophy will be compared between these patient groups.
Evaluations of baseline and 1 year patient characteristics possibly related to moderate vision loss are underway.
At Month 12, 26 (5.4%) of the 478 treated patients from the MARINA trial and 13 patients (4.7%) of the 279 patients from the ANCHOR trial experienced a visual acuity loss of at least 15 letters. Patient and lesion characteristics that may be predictive of the vision loss will be presented.
www.clinicaltrials.gov NCT00056836, NCT000061594
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