gms | German Medical Science

SUSTAIN Study Purpose: 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.

Methods: 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), 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. 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.

Results: 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.

Conclusions: 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. -

EXCITE Study Purpose: To compare the efficacy and safety of two ranibizumab dosing regimens in patients with subfoveal CNV secondary to AMD.

Methods: The EXCITE trial is a randomized, double-masked, multicenter, 12-month trial in patients with choroidal neovascularization secondary to AMD. The EXCITE trial recruited patients aged 50 years or older with neovascular AMD. 354 patients were randomized 1:1:1 to quarterly 0.3 mg or 0.5 mg ranibizumab (monthly for the first three months, then quarterly thereafter; 6 injections over 12 months) or monthly 0.3 mg ranibizumab (12 injections over 12 months). The primary objective was to evaluate the efficacy of two dosing regimens, quarterly versus monthly, determined by the mean change in best-corrected visual acuity (BCVA) from baseline to Month 12. Secondary objectives included safety and changes in visual function and retinal structure.

Results: All three arms experienced the highest VA increase with the first three monthly doses. Over 12 months, the VA increased by 8.3 letters within the 0.3 mg ranibizumab-group monthly compared with 4.9 (0.3 mg) and 3.8 (0.5 mg) letters with the quarterly regimens. Changes in retinal thickness were comparable between the groups, although Months 5, 8, and 11 reflected the trough values of quarterly treatment.

Conclusions: To maintain the initial gain reached within the first three injections a close monitoring followed by adequate reinjections is necessary.