September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Ranibizumab (0.3 MG) For Persistent Diabetic Macular Edema (DME) After Recent, Frequent, And Chronic Bevacizumab: 1-Year Rotate Trial Results
Author Affiliations & Notes
  • Amina Farooq
    Clinical Trial Research, Southeast Retina Center, Evans, Georgia, United States
  • Heather Frazier
    Clinical Trial Research, Southeast Retina Center, Evans, Georgia, United States
  • Chelsea Fechter
    Clinical Trial Research, Southeast Retina Center, Evans, Georgia, United States
  • William Baker Marcus
    Clinical Trial Research, Southeast Retina Center, Evans, Georgia, United States
  • Harinderjit Singh
    Clinical Trial Research, Southeast Retina Center, Evans, Georgia, United States
  • Dennis M Marcus
    Clinical Trial Research, Southeast Retina Center, Evans, Georgia, United States
  • Footnotes
    Commercial Relationships   Amina Farooq, None; Heather Frazier, None; Chelsea Fechter, None; William Marcus, None; Harinderjit Singh, Acucela (F), Alcon (F), Alimera (F), Allergan (F), Chiltern (F), Del Mar (F), Genentech (F), Neurotech (F), Ophthotech (F), Pfizer (F), Regeneron (F), Thrombogenics (F), Xcovery (F); Dennis Marcus, Acucela (F), Alcon (F), Alimera (C), Alimera (F), Allergan (F), Chiltern (F), Del Mar (F), Genentech (C), Genentech (F), Neurotech (F), Ophthotech (F), Pfizer (F), Regeneron (C), Regeneron (F), Thrombogenics (F), Thrombogenics (C), Xcovery (F)
  • Footnotes
    Support  Investigator Initiated Study Supported by Genentech
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2093. doi:
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      Amina Farooq, Heather Frazier, Chelsea Fechter, William Baker Marcus, Harinderjit Singh, Dennis M Marcus; Ranibizumab (0.3 MG) For Persistent Diabetic Macular Edema (DME) After Recent, Frequent, And Chronic Bevacizumab: 1-Year Rotate Trial Results. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2093.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : There is limited prospective data evaluating the safety and efficacy of 0.3 mg ranibizumab for persistent DME after bevacizumab. We evaluated the safety and potential efficacy of 0.3 mg intravitreal ranibizumab in eyes with persistent DME after bevacizumab.

Methods : The ROTATE Trial is an open-label, prospective, unmasked, randomized study of intravitreally administered 0.3 mg ranibizumab in 30 eyes with persistent DME after bevacizumab. Thirty eyes were randomized in a 1:2 ratio to a Sustained group (12 mandatory monthly injections of 0.3 mg ranibizumab through 1 year) or a PRN group (6 mandatory monthly injections of 0.3 mg ranibizumab, followed by criteria-based PRN dosing). Subjects were evaluated monthly for additional ranibizumab or rescue treatment.

Results : Twenty-nine of 30 enrolled eyes have completed 12-month follow-up. At baseline , mean BCVA was 63(Snellen equivalent 20/63) and 64 (Snellen equivalent 20/50) ETDRS letters, in the Sustained and PRN groups, respectively Mean baseline CST was 401 um and 453 um in the Sustained and PRN groups, respectively . At 12 months, mean BCVA was 70 (Snellen equivalent 20/40) and 71 (Snellen equivalent 20/40) letters in the sustained and PRN groups, respectively. Average visual acuity increased 6.7 and 7.1 letters at 12 months from baseline in the Sustained , and PRN groups respectively, with 16 of 30 eyes gaining ≥ 5 letters at 6 months. At 12 months, mean CST was 307 um and 331 um in the Sustained and PRN groups , respectively. Average OCT central subfield thickness thinned 92 um and 129 um at 12 months from baseline in the Sustained and PRN groups, respectively; 22 of 29 eyes decreasing thickness by at least 10% through 6 months. Adverse events included 2 deaths, one patient with multiple comorbidities (renal failure, cirrhosis, and pulmonary congestion secondary to right heart failure), myocardial infarction in one patient, elevated blood pressure (2 patients), and mild posterior subcapsular cataracts in 2 eyes. No endophthalmitis, retinal tears, detachments, or vitreous hemorrhage were observed.

Conclusions : Ranibizumab 0.3 mg may provide additional visual acuity and anatomic benefit for eyes with persistent DME after recent, chronic and frequent bevacizumab.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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