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PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY

Should Baseline Characteristics Affect Choice of Treatment?

Bressler, Susan B. MD*; Beaulieu, Wesley T. PhD; Glassman, Adam R. MS; Gross, Jeffrey G. MD; Melia, Michele ScM; Chen, Eric MD§; Pavlica, Michael R. MD; Jampol, Lee M. MD** for the Diabetic Retinopathy Clinical Research Network

doi: 10.1097/IAE.0000000000002377
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Purpose: Among eyes with proliferative diabetic retinopathy, identify whether baseline characteristics impact the benefit of ranibizumab over panretinal photocoagulation (PRP) in DRCR.net Protocol S.

Methods: Participants had proliferative diabetic retinopathy, visual acuity of 20/320 or better, and no previous PRP. Eyes were randomized to PRP or intravitreous 0.5-mg ranibizumab.

Results: Ranibizumab was superior to PRP for change in visual acuity and development of vision-impairing central-involved diabetic macular edema over 2 years (P < 0.001). Among 25 characteristics, there were none in which participants assigned to PRP had superior outcomes relative to ranibizumab-assigned participants. The relative benefit of ranibizumab over PRP for change in visual acuity seemed greater in participants with higher mean arterial pressure (P = 0.03), without previous focal/grid laser (P = 0.03), with neovascularization of the disk and elsewhere on clinical examination (P = 0.04), and with more advanced proliferative diabetic retinopathy on photographs (P = 0.02). For development of vision-impairing central-involved diabetic macular edema, the relative benefit of ranibizumab over PRP seemed greater among nonwhite participants (P = 0.01) and those with higher mean arterial pressure (P = 0.01).

Conclusion: There were no characteristics identified in which outcomes were superior with PRP compared with ranibizumab. These exploratory analyses provide additional support that ranibizumab may be a reasonable alternative to PRP for proliferative diabetic retinopathy over a 2-year period.

There were no characteristics identified in which change in vision or development of vision-impairing central-involved diabetic macular edema over 2 years was superior with panretinal photocoagulation versus ranibizumab. These results provide additional support that ranibizumab may be a reasonable alternative to panretinal photocoagulation for proliferative diabetic retinopathy over 2 years.

*Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland;

Jaeb Center for Health Research, Tampa, Florida;

Carolina Retina Center PA, Columbia, South Carolina;

§Retina Consultants of Houston, Houston, Texas;

Family Eye Group, Lancaster, Pennsylvania; and

**Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

Reprint requests: Wesley T. Beaulieu, PhD, Jaeb Center for Health Research, 1530 Amberly Drive, Suite 350, Tampa, FL 33647; e-mail: drcrstat8@jaeb.org

Supported by a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, U.S. Department of Health and Human Services EY14231, EY23207, EY18817. Genentech provided ranibizumab for the study and funds to DRCR.net to defray the study's clinical site costs.

A complete list of all DRCR.net investigator financial disclosures can be found at www.drcr.net.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).

The National Institutes of Health participated in oversight of the conduct of the study and review of the manuscript but not directly in the design or conduct of the study nor in the collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Per the DRCR.net Industry Collaboration Guidelines (available at http://www.drcr.net), the DRCR.net had complete control over the design of the protocol, ownership of the data, and all editorial content of presentations and publications related to the protocol.

The study was completed at 55 DRCR.net sites within the United States. A complete list was published in Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Trial. JAMA. 2015; 314(20):2137-2146. doi: 10.1001/jama.2015.15217.

Received May 21, 2018

Accepted October 02, 2018

© 2019 by Ophthalmic Communications Society, Inc.