July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Intravitreal Aflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) after Treatment
with Bevacizumab and/or Ranibizumab: 6-Month ROTATED Trial Results
Author Affiliations & Notes
  • Dennis M Marcus
    Southeast Retina Center, Augusta, Georgia, United States
  • Heather Frazier
    Southeast Retina Center, Augusta, Georgia, United States
  • Priscila Rex
    Southeast Retina Center, Augusta, Georgia, United States
  • William Marcus
    Southeast Retina Center, Augusta, Georgia, United States
  • Davis Starnes
    Southeast Retina Center, Augusta, Georgia, United States
  • Harveen Walia
    Southeast Retina Center, Augusta, Georgia, United States
  • Harinderjit Singh
    Southeast Retina Center, Augusta, Georgia, United States
  • Robert Lalane
    Southeast Retina Center, Augusta, Georgia, United States
  • Footnotes
    Commercial Relationships   Dennis Marcus, Acucela (F), Alcon (F), Allegro (F), Allergan (F), Appellis (F), Astellas (F), Clearside (F), Genentech (F), Genentech (C), GSK (F), Neurotech (F), Novartis (F), OHR (F), Ophthotech (F), Pfner (F), Regeneron (F), Roche (F), Samsung (F), ThromboGenics (F), Tyrogenex (F); Heather Frazier, None; Priscila Rex, None; William Marcus, None; Davis Starnes, None; Harveen Walia, None; Harinderjit Singh, Acucela (F), Alcon (F), Allegro (F), Allergan (F), Appellis (F), Astellas (F), Clearside (F), Genentech (F), GSK (F), Neurotech (F), Novartis (F), OHR (F), Opthotech (F), Pfizer (F), Regeneron (F), Roche (F), ThromboGenetics (F), Tyrogenex (F); Robert Lalane, Clearside (F), Genentech (F), Novartis (F), Opthotech (F), Regeneron (F), Roche (F)
  • Footnotes
    Support  Investigator Initiated Trial Funded by Regeneron
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3598. doi:
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    • Get Citation

      Dennis M Marcus, Heather Frazier, Priscila Rex, William Marcus, Davis Starnes, Harveen Walia, Harinderjit Singh, Robert Lalane; Intravitreal Aflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) after Treatment
      with Bevacizumab and/or Ranibizumab: 6-Month ROTATED Trial Results. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3598.

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

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Abstract

Purpose : There is limited prospective data evaluating the safety and efficacy of 2.0 mg intravitreal aflibercept in eyes with persistent DME after treatment with bevacizumab and/or ranibizumab. We evaluated the safety and efficacy of 2.0 mg intravitreal aflibercept in these eyes with persistent DME despite previous anti-VEGF (vascular endothelial growth factor) therapy.

Methods : The ROTATED Trial is an open-label, prospective, non-randomized, single-center, interventional study of 2.0 mg IAI in eyes with persistent DME after chronic, recent, and frequent bevacizumab and/or ranibizumab. Inclusion criteria required eyes to have received at least 6 bevacizumab/ranibizumab injections within 9 months and at least 2 bevacizumab/ranibizumab injection within 3 months of enrollment. Study eyes received five initial monthly intravitreal aflibercept doses of 2.0 mg followed by 2q8 week intravitreal aflibercept injections for a total of 52 weeks.

Results : Twenty five of 30 anticipated enrolled eyes have completed 24-week follow up. At baseline, mean best-corrected visual acuuity (BCVA) was 65 (Snellen equivalent 20/100) ETDRS letters. Mean baseline OCT central subfield thickness (CST) was 460 um. At 24 weeks, mean BCVA was 69 (Snellen equivalent 20/80) letters. Average BCVA increased 6 letters at 24 weeks, with 18 of 25 eyes gaining ≥ 0 letters at 24 weeks. At 24 weeks, average OCT CST decreased 69 um (mean CST = 408um) from baseline; 13 of 25 eyes decreased CST by at least 10% from baseline through 24 weeks. Adverse events included 2 subconjunctival hemorrhages, blurry vision, trace epiretinal membrane, elevated blood pressure, and vertigo. Serious systemic adverse events included one ruptured hernia and one death due to a myocardial infarction. No endophthalmitis, retinal tears, detachments, or vitreous hemorrhages were observed.

Conclusions : Intravitreal aflibercept may provide additional visual acuity and anatomic benefit for eyes with persistent DME after recent, chronic, and frequent bevacizumab/ranibizumab.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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