June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Baseline predictors of early visual acuity improvement in RVO patients treated with ranibizumab in the SHORE study
Author Affiliations & Notes
  • Mimi Liu
    Colorado Retina Associates, Denver, CO
  • Pin-wen Wang
    Genentech, Inc., South San Francisco, CA
  • Zdenka Haskova
    Genentech, Inc., South San Francisco, CA
  • Footnotes
    Commercial Relationships Mimi Liu, None; Pin-wen Wang, Genentech, Inc. (E); Zdenka Haskova, Genentech, Inc. (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 5802. doi:
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    • Get Citation

      Mimi Liu, Pin-wen Wang, Zdenka Haskova; Baseline predictors of early visual acuity improvement in RVO patients treated with ranibizumab in the SHORE study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5802.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

To identify baseline (BL) predictors of early improvement of visual acuity (VA) in patients with branch or central retinal vein occlusion (RVO) treated with ranibizumab (RBZ) in the 15-month, phase IV, randomized SHORE study (N=202).

 
Methods
 

From Month (M) 0‒6, patients received 7 monthly RBZ 0.5 mg injections. Between M7 and M14, patients continued to receive monthly RBZ injections until the first month at which pre-specified VA and SD-OCT stability criteria were met. Patients were then randomized 1:1 to continue RBZ monthly or switch to RBZ PRN. Among the patients who met stability criteria during the study, 80% were randomized by M8; 15% of patients were not randomized (ie, discontinued prior to randomization or never met stability criteria through M14), and continued to receive monthly injections throughout the study. Kaplan-Meier analyses were conducted to estimate time to first clinically significant improvement in best-corrected VA (BCVA) defined as gaining of ≥15 letters from BL or achieving Snellen equivalent of 20/40 or better. BL demographics and characteristics were explored as predictors of early VA improvement.

 
Results
 

BL factors associated with early improvement to ≥20/40 vision included larger total macular volume (>9.99 mm3), higher BCVA (>50 letters), and presence of subretinal fluid. At M1, 51% of patients achieved ≥20/40 vision. The median time to achieve ≥20/40 vision was 59 days (excluding 22 patients [10.9%] with ≥20/40 vision at M0) and 81% achieved ≥20/40 vision at least one time during the study. At M15, 72% of patients achieved ≥20/40 vision. BL factors associated with an early gain of ≥15-letters included lower BCVA (≤50 letters) and male gender. At M1, 39% of patients gained ≥15 letters from BL. The median time to ≥15-letter gain from BL was 63 days and 85% of all patients gained ≥15 letters at least one time during the study. At M15, 67% of patients gained ≥15 letters.

 
Conclusions
 

Rapid improvements in VA to ≥20/40 and gain of ≥15-letters were seen in BRVO and CRVO patients within a median of ~2 months of initiating RBZ therapy. Early improvement to 20/40 was associated with larger total macular volumes, subretinal fluid on BL OCT, and BL BCVA >50 letters. Understanding BL characteristics that are predictive of early VA response to RBZ treatment may be used to guide patients’ and physicians’ expectations at the start of therapy.

 
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