PMID- 21459217
OWN - NLM
STAT- MEDLINE
DCOM- 20110606
LR  - 20220331
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 118
IP  - 4
DP  - 2011 Apr
TI  - Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular 
      age-related macular degeneration: the SUSTAIN study.
PG  - 663-71
LID - 10.1016/j.ophtha.2010.12.019 [doi]
AB  - 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-naive 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 mum from baseline to 
      month 3 and -91.5 mum 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.
CI  - Copyright (c) 2011 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Holz, Frank G
AU  - Holz FG
AD  - Department of Ophthalmology, University of Bonn, Bonn, Germany. 
      Frank.Holz@ukb.uni-bonn.de
FAU - Amoaku, Winfried
AU  - Amoaku W
FAU - Donate, Juan
AU  - Donate J
FAU - Guymer, Robyn H
AU  - Guymer RH
FAU - Kellner, Ulrich
AU  - Kellner U
FAU - Schlingemann, Reinier O
AU  - Schlingemann RO
FAU - Weichselberger, Andreas
AU  - Weichselberger A
FAU - Staurenghi, Giovanni
AU  - Staurenghi G
CN  - SUSTAIN Study Group
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (VEGFA protein, human)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - ZL1R02VT79 (Ranibizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Female
MH  - Fluorescein Angiography
MH  - Humans
MH  - Intravitreal Injections
MH  - Male
MH  - Middle Aged
MH  - Ranibizumab
MH  - Retina/pathology
MH  - Retreatment
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/antagonists & inhibitors
MH  - Visual Acuity/physiology
MH  - Wet Macular Degeneration/*drug therapy/physiopathology
EDAT- 2011/04/05 06:00
MHDA- 2011/06/07 06:00
CRDT- 2011/04/05 06:00
PHST- 2010/01/21 00:00 [received]
PHST- 2010/12/14 00:00 [revised]
PHST- 2010/12/17 00:00 [accepted]
PHST- 2011/04/05 06:00 [entrez]
PHST- 2011/04/05 06:00 [pubmed]
PHST- 2011/06/07 06:00 [medline]
AID - S0161-6420(10)01372-2 [pii]
AID - 10.1016/j.ophtha.2010.12.019 [doi]
PST - ppublish
SO  - Ophthalmology. 2011 Apr;118(4):663-71. doi: 10.1016/j.ophtha.2010.12.019.