PMID- 21146229
OWN - NLM
STAT- MEDLINE
DCOM- 20110708
LR  - 20220321
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 118
IP  - 5
DP  - 2011 May
TI  - Efficacy and safety of monthly versus quarterly ranibizumab treatment in 
      neovascular age-related macular degeneration: the EXCITE study.
PG  - 831-9
LID - 10.1016/j.ophtha.2010.09.004 [doi]
AB  - OBJECTIVE: To demonstrate noninferiority of a quarterly treatment regimen to a 
      monthly regimen of ranibizumab in patients with subfoveal choroidal 
      neovascularization (CNV) secondary to age-related macular degeneration (AMD). 
      DESIGN: A 12-month, multicenter, randomized, double-masked, active-controlled, 
      phase IIIb study. PARTICIPANTS: Patients with primary or recurrent subfoveal CNV 
      secondary to AMD (353 patients), with predominantly classic, minimally classic, 
      or occult (no classic component) lesions. INTERVENTION: Patients were randomized 
      (1:1:1) to 0.3 mg quarterly, 0.5 mg quarterly, or 0.3 mg monthly doses of 
      ranibizumab. Treatment comprised of a loading phase (3 consecutive monthly 
      injections) followed by a 9-month maintenance phase (either monthly or quarterly 
      injection). MAIN OUTCOME MEASURES: Mean change in best-corrected visual acuity 
      (BCVA) and central retinal thickness (CRT) from baseline to month 12 and the 
      incidence of adverse events (AEs). RESULTS: In the per-protocol population (293 
      patients), BCVA, measured by Early Treatment Diabetic Retinopathy Study-like 
      charts, increased from baseline to month 12 by 4.9, 3.8, and 8.3 letters in the 
      0.3 mg quarterly (104 patients), 0.5 mg quarterly (88 patients), and 0.3 mg 
      monthly (101 patients) dosing groups, respectively. Similar results were observed 
      in the intent-to-treat (ITT) population (353 patients). The mean decrease in CRT 
      from baseline to month 12 in the ITT population was -96.0 mum in 0.3 mg quarterly, 
      -105.6 mum in 0.5 mg quarterly, and -105.3 mum in 0.3 mg monthly group. The most 
      frequent ocular AEs were conjunctival hemorrhage (17.6%, pooled quarterly groups; 
      10.4%, monthly group) and eye pain (15.1%, pooled quarterly groups; 20.9%, 
      monthly group). There were 9 ocular serious AEs and 3 deaths; 1 death was 
      suspected to be study related (cerebral hemorrhage; 0.5 mg quarterly group). The 
      incidences of key arteriothromboembolic events were low. CONCLUSIONS: After 3 
      initial monthly ranibizumab injections, both monthly (0.3 mg) and quarterly (0.3 
      mg/0.5 mg) ranibizumab treatments maintained BCVA in patients with CNV secondary 
      to AMD. At month 12, BCVA gain in the monthly regimen was higher than that of the 
      quarterly regimens. The noninferiority of a quarterly regimen was not achieved 
      with reference to 5.0 letters. The safety profile was similar to that reported in 
      prior ranibizumab studies.
CI  - Copyright (c) 2011 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Schmidt-Erfurth, Ursula
AU  - Schmidt-Erfurth U
AD  - Department of Ophthalmology, University of Vienna, Waehringer Guertel, Vienna, 
      Austria. ursula.schmidt-erfurth@meduniwien.ac.at
FAU - Eldem, Bora
AU  - Eldem B
FAU - Guymer, Robyn
AU  - Guymer R
FAU - Korobelnik, Jean-Francois
AU  - Korobelnik JF
FAU - Schlingemann, Reinier O
AU  - Schlingemann RO
FAU - Axer-Siegel, Ruth
AU  - Axer-Siegel R
FAU - Wiedemann, Peter
AU  - Wiedemann P
FAU - Simader, Christian
AU  - Simader C
FAU - Gekkieva, Margarita
AU  - Gekkieva M
FAU - Weichselberger, Andreas
AU  - Weichselberger A
CN  - EXCITE Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101213
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  - 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  - Choroidal Neovascularization/diagnosis/*drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Fluorescein Angiography
MH  - Humans
MH  - Intravitreal Injections
MH  - Macular Degeneration/diagnosis/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Ranibizumab
MH  - Retina/pathology
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/*antagonists & inhibitors
MH  - Visual Acuity/physiology
EDAT- 2010/12/15 06:00
MHDA- 2011/07/09 06:00
CRDT- 2010/12/15 06:00
PHST- 2009/12/19 00:00 [received]
PHST- 2010/09/06 00:00 [revised]
PHST- 2010/09/08 00:00 [accepted]
PHST- 2010/12/15 06:00 [entrez]
PHST- 2010/12/15 06:00 [pubmed]
PHST- 2011/07/09 06:00 [medline]
AID - S0161-6420(10)00972-3 [pii]
AID - 10.1016/j.ophtha.2010.09.004 [doi]
PST - ppublish
SO  - Ophthalmology. 2011 May;118(5):831-9. doi: 10.1016/j.ophtha.2010.09.004. Epub 
      2010 Dec 13.