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

Abstract

PURPOSE:

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.

• Authors: Robert B Bhisitkul, Peter A Campochiaro, Howard Shapiro, Roman G Rubio
• Journal: Ophthalmology (Ophthalmology) Vol. 120 Issue 5 Pg. 1057-63 (May 2013) ISSN: 1549-4713 [Electronic] United States
• PMID: 23415775 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 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