Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study
Ophthalmology, 2011•Elsevier
Objective To evaluate the safety and efficacy of individualized ranibizumab treatment in
patients with neovascular age-related macular degeneration. Design Twelve-month, phase
III, multicenter, open-label, single-arm study. Participants A total of 513 ranibizumab-naïve
SUSTAIN patients. Intervention Three initial monthly injections of ranibizumab (0.3 mg) and
thereafter pro re nata (PRN) retreatment for 9 months based on prespecified retreatment
criteria. Patients switched to 0.5 mg ranibizumab after approval in Europe. Main Outcome …
patients with neovascular age-related macular degeneration. Design Twelve-month, phase
III, multicenter, open-label, single-arm study. Participants A total of 513 ranibizumab-naïve
SUSTAIN patients. Intervention Three initial monthly injections of ranibizumab (0.3 mg) and
thereafter pro re nata (PRN) retreatment for 9 months based on prespecified retreatment
criteria. Patients switched to 0.5 mg ranibizumab after approval in Europe. Main Outcome …
Objective
To evaluate the safety and efficacy of individualized ranibizumab treatment in patients with neovascular age-related macular degeneration.
Design
Twelve-month, phase III, multicenter, open-label, single-arm study.
Participants
A total of 513 ranibizumab-naïve SUSTAIN patients.
Intervention
Three initial monthly injections of ranibizumab (0.3 mg) and thereafter pro re nata (PRN) retreatment for 9 months based on prespecified retreatment criteria. Patients switched to 0.5 mg ranibizumab after approval in Europe.
Main Outcome Measures
Frequency of adverse events (AEs), monthly change of best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline, the time to first re-treatment, and the number of treatments were assessed.
Results
A total of 249 patients (48.5%) reported ocular AEs, and 8 (1.5%) deaths, 5 (1.2%) patients with ocular serious AEs of the study eye (retinal hemorrhage, cataract, retinal pigment epithelial tear, reduced visual acuity [VA], vitreous hemorrhage), and 19 (3.7%) patients with arteriothromboembolic events were observed. Most frequent AEs in the study eye were reduced VA (18.5%), retinal hemorrhage (7.2%), increased intraocular pressure (7.0%), and conjunctival hemorrhage (5.5%). The average number of re-treatments from months 3 to 11 was 2.7. Mean best-corrected visual acuity increased steadily from baseline to month 3 to reach +5.8 letters, decreased slightly from month 3 to 6, and remained stable from month 6 to 12, reaching +3.6 at month 12. Mean change in CRT was −101.1 μm from baseline to month 3 and −91.5 μm from baseline to month 12.
Conclusions
The safety results are comparable to the favorable tolerability profile of ranibizumab observed in previous pivotal clinical studies; individualized treatment with less than monthly re-treatments shows a similar safety profile as observed in previous randomized clinical trials with monthly ranibizumab treatment. Efficacy outcomes were achieved with a low average number of re-treatments. Visual acuity in SUSTAIN patients with individualized re-treatment based on VA/optical coherence tomography assessment reached on average a maximum after the first 3 monthly injections, decreased slightly under PRN during the next 2 to 3 months, and was then sustained throughout the treatment period.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
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