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Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography.

AbstractPURPOSE:
To determine if optical coherence tomography (OCT) at baseline or month 3 in the Treatment of Macular Edema following Branch Retinal Vein Occlusion: Evaluation of Efficacy and Safety (BRAVO) and Treatment of Macular Edema following Central Retinal Vein Occlusion: Evaluation of Efficacy and Safety (CRUISE) studies provides information that predicts visual outcome.
DESIGN:
Post hoc analysis from 2 prospective, randomized, controlled clinical trials.
PARTICIPANTS:
Three hundred ninety-seven patients from the BRAVO study and 392 patients from the CRUISE study.
METHODS:
Time-domain OCT imaging data were analyzed.
MAIN OUTCOME MEASURES:
Mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6 and month 12.
RESULTS:
Among ranibizumab-treated patients, 71.2% (0.3 mg) and 78.5% (0.5 mg) in the CRUISE study and 79.1% (0.3 mg) and 84.7% (0.5 mg) in the BRAVO study had central foveal thickness (CFT) of 250 μm or less at month 3 and therefore were categorized as early ranibizumab responders. Early ranibizumab responders had excellent visual outcomes regardless of ranibizumab dose; mean improvement in BCVA letter score at 6 and 12 months was 15.0 to 16.5 (central retinal vein occlusion [CRVO]) and 17.4 to 19.1 (branch retinal vein occlusion [BRVO]). Late or incomplete ranibizumab responders with CRVO (CFT >250 μm at month 3) did not fare as well as early responders if they were treated with 0.3 mg ranibizumab (month 6, P = 0.012). At month 6, compared with ranibizumab-treated CRVO patients with resolved cystoid macular edema (CME) at month 3, those with persistent CME did worse, on average, and significantly so for 0.5 mg (13.1 vs. 18.6; P = 0.027). At baseline, subretinal fluid (SRF) was present in 57% of patients with CRVO and in 45% of patients with BRVO; its presence did not portend a poor outcome in patients treated with ranibizumab for whom SRF was eliminated in almost all by month 3.
CONCLUSIONS:
At month 3 of ranibizumab treatment, OCT images provide predictive information for patients with CRVO, but not for those with BRVO. Visual outcome at months 6 and 12 was reduced in 0.5 mg ranibizumab-treated patients with CRVO who had persistent CME at month 3. It also was reduced in CRVO for those with CFT of more than 250 μm at month 3 who were treated with 0.3 mg ranibizumab. The findings suggest that late or incomplete responders may need careful follow-up.
FINANCIAL DISCLOSURE(S):
Proprietary or commercial disclosure may be found after the references.
AuthorsRobert B Bhisitkul, Peter A Campochiaro, Howard Shapiro, Roman G Rubio
JournalOphthalmology (Ophthalmology) Vol. 120 Issue 5 Pg. 1057-63 (May 2013) ISSN: 1549-4713 [Electronic] United States
PMID23415775 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Ranibizumab
Topics
  • Angiogenesis Inhibitors (therapeutic use)
  • Antibodies, Monoclonal, Humanized (therapeutic use)
  • Humans
  • Macular Edema (drug therapy, etiology)
  • Predictive Value of Tests
  • Prospective Studies
  • Ranibizumab
  • Retinal Vein Occlusion (complications, drug therapy)
  • Tomography, Optical Coherence
  • Visual Acuity

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