Safety and Efficacy of a Flexible Dosing Regimen of Ranibizumab in Neovascular Age-Related Macular Degeneration: The SUSTAIN Study

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• 作者：Frank G. Holz MD¹ ; ^{Frank.Holz@ukb.uni-bonn.de} ; Winfried Amoaku MD ; PhD² ; Juan Donate MD³ ; Robyn H. Guymer MD⁴ ; Ulrich Kellner MD⁵ ; Reinier O. Schlingemann MD⁶ ; Andreas Weichselberger PhD⁷ ; Giovanni Staurenghi MD⁸ ; SUSTAIN Study Group
• 刊名：Ophthalmology
• 出版年：2011
• 出版时间：April 2011
• 年：2011
• 卷：118
• 期：4
• 页码：663-671
• 全文大小：687 K

文摘

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.