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ASSOCIATION BETWEEN EARLY ANATOMIC RESPONSE TO ANTI–VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY AND LONG-TERM OUTCOME IN DIABETIC MACULAR EDEMA: AN INDEPENDENT ANALYSIS OF PROTOCOL I STUDY DATA

Dugel, Pravin U., MD*,†; Campbell, Joanna H., PhD; Kiss, Szilárd, MD§; Loewenstein, Anat, MD; Shih, Vanessa, PharmD; Xu, Xiaoshu, MS; Holekamp, Nancy M., MD**; Augustin, Albert J., MD, PhD††; Ho, Allen C., MD‡‡; Gonzalez, Victor H., MD§§; Whitcup, Scott M., MD¶¶

doi: 10.1097/IAE.0000000000002110
Original Study: PDF Only

Purpose: This post hoc analysis explores the relationship between early retinal anatomical response and long-term anatomical and visual outcomes with ranibizumab in center-involved diabetic macular edema.

Methods: Eyes randomized to the ranibizumab plus prompt laser and ranibizumab plus deferred laser treatment arms in the Protocol I study were categorized according to their proportional reduction (<20 vs. ≥20%) in central retinal thickness (CRT) after 12 weeks. Adjusted and unadjusted analyses assessed the association between early (Week 12) anatomical response and long-term (Weeks 52 and 156) anatomical and best-corrected visual acuity outcomes.

Results: Of 335 study eyes, 118 showed limited (<20%) and 217 showed strong (≥20%) CRT reduction at Week 12. In unadjusted and adjusted analyses, limited early CRT response was negatively and significantly associated with strong CRT response at Weeks 52 and 156. Sensitivity analyses indicated that this association was robust and unrelated to any “floor effect.” In unadjusted analyses, a strong early CRT response was associated with greater long-term improvement in best-corrected visual acuity; after controlling for confounders, the association lost statistical significance.

Conclusion: Early CRT response to ranibizumab is a significant prognostic indicator of medium- to long-term anatomical outcome in center-involved diabetic macular edema.

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*Retinal Consultants of Arizona, Phoenix, Arizona;

USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California;

Allergan plc, Irvine, California;

§Department of Ophthalmology, Weill Cornell Medical College, New York, New York;

Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;

**Pepose Vision Institute and Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, Missouri;

††Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany;

‡‡Mid Atlantic Retina, Plymouth Meeting, Pennsylvania;

§§Valley Retina Institute, McAllen, Texas; and

¶¶Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, California.

Reprint requests: Pravin U. Dugel, MD, Retinal Consultants of Arizona, 1101 E. Missouri Avenue, P.O. Box 32530, Phoenix, AZ 85014-2709; e-mail: pdugel@gmail.com

Presented in part at the American Society of Retina Specialists 34th Annual Meeting, San Francisco, California, August 9 to 14, 2016; the 16th Congress of the European Retina, Macula and Vitreous Society, Copenhagen, Denmark, September 8 to 11, 2016; and Hawaiian Eye 2017, Koloa, Hawaii, January 14 to 20, 2017.

None of the authors has any financial/conflicting interests to disclose.

This study was sponsored by Allergan plc, Dublin, Ireland.

The authors have no proprietary interest on the content described in the article. J. H. Campbell, V. Shih, and X. Xu are employees of Allergan plc.

Medical writing and editorial assistance were provided to the authors by Andrew Fitton, PhD, of Evidence Scientific Solutions (Horsham, United Kingdom) and funded by Allergan plc, Dublin, Ireland. All authors met the ICMJE authorship criteria. No honoraria or payments were made for authorship. The source of the data is the DRCR.net, but the analyses, content, and conclusions presented herein are solely the responsibility of the authors and have not been reviewed or approved by DRCR.net.

© 2018 by Ophthalmic Communications Society, Inc.