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Original Investigation
Clinical Trial
December 22, 2016

Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular EdemaSubanalysis of the VISTA and VIVID Randomized Clinical Trials

Author Affiliations
  • 1Retina Consultants of Houston, Houston, Texas
  • 2Southeast Retina Center, Augusta, Georgia
  • 3Department of Ophthalmology, University of Padova, Padova, Italy
  • 4Service d’Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
  • 5University Bordeaux, Institut de Santé Publique, d’Epidémiologie et de Développement (ISPED), Bordeaux, France
  • 6Institut National de la Santé et de la Récherche Médicale Unité 1219, Bordeaux Population Health Research Center, Bordeaux, France
  • 7Regeneron Pharmaceuticals, Inc, Tarrytown, New York
  • 8Bayer HealthCare Pharmaceuticals, Berlin, Germany
  • 9University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  • 10Ophthalmic Consultants of Boston, Boston, Massachusetts
JAMA Ophthalmol. Published online December 22, 2016. doi:10.1001/jamaophthalmol.2016.4912
Key Points

Question  In a post hoc analysis of the VISTA and VIVID trials, was there visual acuity improvement with intravitreal aflibercept injection after substantial visual acuity loss at least 24 weeks after macular laser photocoagulation treatment for persistent diabetic macular edema?

Findings  In these randomized clinical trials, eyes with substantial visual acuity loss at least 24 weeks after macular laser photocoagulation treatment subsequently receiving intravitreal aflibercept injection had mean gains from baseline to week 100 of 2.2 (VISTA) and 3.8 (VIVID) letters. After initiating intravitreal aflibercept injection, the mean gain was 17.4 (VISTA) and 13.6 (VIVID) letters through week 100.

Meaning  Intravitreal aflibercept injection results in substantial visual acuity gains among eyes with substantial visual acuity loss at least 24 weeks after macular laser photocoagulation treatment for diabetic macular edema.

Abstract

Importance  Information on the effect of anti–vascular endothelial growth factor therapy in eyes with diabetic macular edema (DME) with vision loss after macular laser photocoagulation is clinically valuable.

Objective  To evaluate visual and anatomic outcomes in a subgroup of macular laser photocoagulation treatment control (hereafter laser control) eyes with substantial vision loss receiving treatment with intravitreal aflibercept injection.

Design, Setting, and Participants  This investigation was a post hoc analysis of a subgroup of laser control eyes in 2 phase 3 trials—VISTA (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) and VIVID (Intravitreal Aflibercept Injection in Vision Impairment Due to DME)—in a multicenter setting. One hundred nine laser control eyes with center-involving DME were included.

Interventions  Treatment with intravitreal aflibercept injection (2 mg) every 8 weeks after 5 monthly doses with sham injections on nontreatment visits starting at week 24 was initiated on meeting prespecified criteria of at least a 10-letter visual acuity loss at 2 consecutive visits or at least a 15-letter visual acuity loss from the best previous measurement at 1 visit and vision not better than at baseline.

Main Outcomes and Measures  Visual and anatomic outcomes in a subgroup of laser control eyes receiving treatment with intravitreal aflibercept injection.

Results  Through week 100, a total of 63 of 154 eyes (40.9%) in VISTA and 46 of 133 eyes (34.6%) in VIVID initially randomized to laser control received treatment with intravitreal aflibercept injection. The median time from week 24 to the first intravitreal aflibercept injection treatment was 34.0 (VISTA) and 83.5 (VIVID) days. In this subgroup, the mean (SD) visual gain from baseline to week 100 was 2.2 (12.5) (VISTA) and 3.8 (10.1) (VIVID) letters. At the time of intravitreal aflibercept injection initiation, these eyes had a mean (SD) loss of 11.0 (10.1) (VISTA) and 10.0 (6.5) (VIVID) letters from baseline, and they subsequently gained a mean (SD) of 17.4 (9.7) (VISTA) and 13.6 (8.6) (VIVID) letters from the initiation of treatment with intravitreal aflibercept injection through week 100. There was a minimal mean change in central subfield thickness from baseline in these eyes at the time of intravitreal aflibercept injection initiation (an increase of 3.9 μm in VISTA and a decrease of 3.0 μm in VIVID), after which further mean (SD) reductions of 285.6 (202.6) μm (VISTA) and 313.4 (181.9) μm (VIVID) occurred through week 100.

Conclusions and Relevance  Intravitreal aflibercept injection improves visual and anatomic outcomes in eyes experiencing substantial vision loss after macular laser photocoagulation treatment for DME.

Trial Registration  clinicaltrials.gov Identifiers: NCT01363440 and NCT01331681

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