June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) for Treatment of Macular Edema Following Branch Retinal Vein Occlusion (BRVO): 52-Week Results of the VIBRANT Study
Author Affiliations & Notes
  • David S Boyer
    Ophthalmology, Retina Vitreous Assoc Med Group, Los Angeles, CA
  • Footnotes
    Commercial Relationships David Boyer, Aerpio (C), Alcon (C), Alcon (R), Allergan (C), Allergan (R), Bayer (C), Genentech (C), Genentech (R), GS (C), KalVista (C), Neurotech (C), Nicox, Inc (C), Novartis (C), Novartis (R), Ohr (C), Regeneron (R), Regeneron Pharmaceuticals, Inc. (C), Santaris (C), Santen (C), ThromboGenics (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 3749. doi:
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    • Get Citation

      David S Boyer; Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) for Treatment of Macular Edema Following Branch Retinal Vein Occlusion (BRVO): 52-Week Results of the VIBRANT Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3749.

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

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Abstract

Purpose: To evaluate the efficacy and safety of IAI compared with laser grid photocoagulation in macular edema following BRVO.

Methods: VIBRANT was a double-masked, 52-week, phase 3 trial that randomized 183 BRVO eyes with macular edema to treatment with either IAI 2 mg every 4 weeks from baseline through week 24 or grid laser at baseline. From week 24, IAI eyes received IAI 2 mg every 8 weeks and, if needed, laser rescue at week 36; eyes in the laser group that required rescue received IAI 2 mg every 8 weeks after 3 monthly doses. The primary endpoint was the proportion of eyes that gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline at week 24.

Results: The proportions of eyes that gained ≥15 letters from baseline were 52.7% for the IAI group vs 26.7% for the laser group (P=0.0003) at week 24, and 57.1% for the IAI group vs 41.1% for the laser/IAI group (P=0.0296) at week 52. The corresponding mean change from baseline BCVA was 17.0 vs 6.9 letters (P<0.0001) at week 24, and 17.1 vs 12.2 letters (P=0.0035) at week 52 for the IAI and laser/IAI groups, respectively. The corresponding mean CRT reduction from baseline was 280.5 vs 128.0 µm (P<0.0001) at week 24, and 283.9 vs 249.3 µm (P=0.0218) at week 52, respectively. During weeks 24-48, 67 laser eyes (67/83 eyes completing week 24 [80.7%]) received a mean of 4.4 IAI; the median time (range) to the first rescue IAI was 24.9 weeks (23.1-48.4 weeks). Overall, 9 IAI eyes (9/85 eyes completing week 24 [10.6%]) received rescue laser at week 36. Traumatic cataract in an IAI patient (1.1%) was the only ocular serious adverse event that occurred in 52 weeks. One non-fatal stroke (1.1%) occurred before week 24 in a laser patient, and one non-fatal myocardial infarction (1.1%) occurred after week 24 in a laser/IAI patient who had received IAI.

Conclusions: IAI 2q4 provided statistically significant and clinically relevant visual benefits over laser at week 24. IAI given every 8 weeks maintained these improvements through week 52.

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