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C. H. Meyer, N. Eter, F. G. Holz, SUSTAIN Study Group; Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration. Interim Results From the Sustain Trial. Invest. Ophthalmol. Vis. Sci. 2008;49(13):273.
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To provide ranibizumab safety and efficacy interim results from the ongoing SUSTAIN trial. The study is assessing the safety and efficacy of ranibizumab over 12 months in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in a dosing regimen individualized to patient requirements.
This open-label study recruited patients with subfoveal CNV secondary to AMD who were either ranibizumab-naïve or had completed treatment with ranibizumab or verteporfin photodynamic therapy in the ANCHOR trial. Patients received three consecutive monthly injections of ranibizumab 0.3 mg (or 0.5 mg for the ANCHOR patients) [the ‘loading phase’], followed by monthly monitoring visits. Further treatment was administered if visual acuity (VA) decreased by >5 letters or if central retinal thickness (CRT) increased by >100 µm. Treatment was withheld if VA was >79 letters or if CRT was <225 µm. The primary objective was to determine the incidence of ocular adverse events over 12 months. Secondary objectives included the mean changes in VA and CRT and the mean number of treatments over the study period.
A total of 531 patients were enrolled in the study; 69 patients who were ranibizumab-naïve have completed their 12-month visit and were included in this interim analysis. Among these patients, 52% (36/69) had ocular adverse events; these events were serious in only 3% (2/69) of patients (1 retinal hemorrhage and 1 retinal pigment epithelial detachment). Compared with baseline, mean VA at Month 12 increased by approximately 7 letters and mean (SD) CRT decreased at Month 12 by -74.4 (103.0) µm. Over 12 months, the mean (SD) number of ranibizumab injections received by these ranibizumab-naïve patients was 5.3 (2.2), including the three ‘loading’ injections.
The gain in, and subsequent stabilization of, VA observed in ranibizumab-naïve patients in the SUSTAIN trial was mirrored by changes in the retinal structure. These efficacy outcomes were obtained with an overall low mean number of treatments.
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