PMID- 22301066
OWN - NLM
STAT- MEDLINE
DCOM- 20120517
LR  - 20220409
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 119
IP  - 4
DP  - 2012 Apr
TI  - Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up 
      in the HORIZON trial.
PG  - 802-9
LID - 10.1016/j.ophtha.2011.12.005 [doi]
AB  - PURPOSE: To assess long-term safety and efficacy of intraocular ranibizumab 
      injections in patients with macular edema after retinal vein occlusion (RVO). 
      DESIGN: Open-label extension trial of the 12-month Ranibizumab for the Treatment 
      of Macular Edema following Branch Retinal Vein Occlusion: Evaluation of Efficacy 
      and Safety (BRAVO) and Central Retinal Vein Occlusion Study: Evaluation of 
      Efficacy and Safety (CRUISE) trials. PARTICIPANTS: We included 304 patients who 
      completed BRAVO and 304 patients who completed CRUISE. METHODS: Patients were 
      seen at least every 3 months and given an intraocular injection of 0.5 mg 
      ranibizumab if they met prespecified retreatment criteria. MAIN OUTCOME MEASURES: 
      Primary outcomes were incidence and severity of ocular and nonocular adverse 
      events (AEs). Key efficacy outcomes included mean change from baseline 
      best-corrected visual acuity (BCVA) letter score by Early Treatment Diabetic 
      Retinopathy Study protocol and central foveal thickness. RESULTS: In patients who 
      completed month 12, the mean number of injections (excluding month 12 injection) 
      in the sham/0.5-, 0.3/0.5-, and 0.5-mg groups was 2.0, 2.4, and 2.1 (branch RVO) 
      and 2.9, 3.8, and 3.5 (central RVO), respectively. The incidence of study eye 
      ocular serious AEs (SAEs) and SAEs potentially related to systemic vascular 
      endothelial growth factor inhibition across treatment arms was 2% to 9% and 1% to 
      6%, respectively. The mean change from baseline BCVA letter score at month 12 in 
      branch RVO patients was 0.9 (sham/0.5 mg), -2.3 (0.3/0.5 mg), and -0.7 (0.5 mg), 
      respectively. The mean change from baseline BCVA at month 12 in central RVO 
      patients was -4.2 (sham/0.5 mg), -5.2 (0.3/0.5 mg), and -4.1 (0.5 mg), 
      respectively. CONCLUSIONS: No new safety events were identified with long-term 
      use of ranibizumab; rates of SAEs potentially related to treatment were 
      consistent with prior ranibizumab trials. Reduced follow-up and fewer ranibizumab 
      injections in the second year of treatment were associated with a decline in 
      vision in central RVO patients, but vision in branch RVO patients remained 
      stable. Results suggest that during the second year of ranibizumab treatment of 
      RVO patients, follow-up and injections should be individualized and, on average, 
      central RVO patients may require more frequent follow-up than every 3 months.
CI  - Copyright (c) 2012 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Heier, Jeffrey S
AU  - Heier JS
AD  - Ophthalmic Consultants of Boston, Boston, Massachusetts, USA.
FAU - Campochiaro, Peter A
AU  - Campochiaro PA
FAU - Yau, Linda
AU  - Yau L
FAU - Li, Zhengrong
AU  - Li Z
FAU - Saroj, Namrata
AU  - Saroj N
FAU - Rubio, Roman G
AU  - Rubio RG
FAU - Lai, Phillip
AU  - Lai P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120201
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - ZL1R02VT79 (Ranibizumab)
SB  - IM
MH  - Aged
MH  - Angiogenesis Inhibitors/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Female
MH  - Fluorescein Angiography
MH  - Follow-Up Studies
MH  - Humans
MH  - Intravitreal Injections
MH  - Macular Edema/*drug therapy/etiology/physiopathology
MH  - Male
MH  - Ranibizumab
MH  - Retinal Vein Occlusion/complications/*drug therapy/physiopathology
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
MH  - Visual Acuity/physiology
EDAT- 2012/02/04 06:00
MHDA- 2012/05/18 06:00
CRDT- 2012/02/04 06:00
PHST- 2011/06/30 00:00 [received]
PHST- 2011/10/07 00:00 [revised]
PHST- 2011/12/06 00:00 [accepted]
PHST- 2012/02/04 06:00 [entrez]
PHST- 2012/02/04 06:00 [pubmed]
PHST- 2012/05/18 06:00 [medline]
AID - S0161-6420(11)01151-1 [pii]
AID - 10.1016/j.ophtha.2011.12.005 [doi]
PST - ppublish
SO  - Ophthalmology. 2012 Apr;119(4):802-9. doi: 10.1016/j.ophtha.2011.12.005. Epub 
      2012 Feb 1.