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`ORIGINAL ARTICLE
`
`Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred
`Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular
`Edema
`•
`The Diabetic Retinopathy Clinical Research Network •
`Michael J. Elman, MD Lloyd Paul Aiello, MD, PhD
`•
`•
`•
`Ingrid U. Scott, MD, MPH Cynthia R. Stockdale, MSPH Jennifer K. Sun, MD, MPH
`...
`
`•
`•
`
`
`
`Published: April 28, 2010 • DOI: https://doi.org/10.1016/j.ophtha.2010.02.031
`
`References
`
`Article info
`
`Related Articles
`
`Objective
`Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with
`focal/grid laser alone for treatment of diabetic macular edema (DME).
`
`Design
`Multicenter, randomized clinical trial.
`
`Participants
`A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to
`20/320 and DME involving the fovea.
`
`Methods
`Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser
`(n=187), 0.5 mg ranibizumab + deferred (≥24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser
`(n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system.
`
`Main Outcome Measures
`Best-corrected visual acuity and safety at 1 year.
`
`Results
`The 1-year mean change (±standard deviation) in the visual acuity letter score from baseline was significantly
`greater in the ranibizumab + prompt laser group (+9±11, P<0.001) and ranibizumab + deferred laser group
`(+9±12, P<0.001) but not in the triamcinolone + prompt laser group (+4±13, P=0.31) compared with the sham
`+ prompt laser group (+3±13). Reduction in mean central subfield thickness in the triamcinolone + prompt
`laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the
`subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt
`laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study
`treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups,
`whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone +
`prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes.
`
`Conclusions
`Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with
`prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this
`study, although uncommonly associated with endophthalmitis, should be considered for patients with DME
`and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone +
`prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure
`elevation.
`
`Financial Disclosure(s)
`Proprietary or commercial disclosure may be found after the references.
`
`To read this article in full you will need to make a payment
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`1/6
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`|
`
` VOLUME 117, ISSUE 6
`
`,
`
`P1064-1077.E35,
`
`JUNE 2010
`
`⁎
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`Article info
`Publication history
`Published online: April 28, 2010
`Accepted: February 26, 2010
`Received in revised form: February 26, 2010
`Received: January 22, 2010
`Available online: April 27, 2010.
`Footnotes
`Manuscript no. 2010-112.
`
`The most recently published list of the DRCR.net investigators and staff who participated in this study is
`available at www.drcr.net.
`
`Correspondence: Protocol I Correspondence, Jaeb Center for Health Research, 15310 Amberly Drive, Suite
`350, Tampa, FL 33647. E-mail: drcrstat4@jaeb.org
`
`This article contains online-only material. The following should appear online-only: Table 1, Table 2, Table 3,
`Table 4, Table 6, Table 7, Table 9, Table 10, Table 12, Table 13, Table 14, Table 16, Table 18, Table 19;
`Figure 1, Figure 2, Figure 5, Figure 7, Figure 8; Appendix 1, Appendix 2, Appendix 3, Appendix 4, Appendix
`5. (website).
`
`Financial Disclosure(s): Supported through a cooperative agreement from the National Eye Institute and the
`National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department
`of Health and Human ServicesEY14231, EY14229, and EY018817.
`
`The funding organization (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; the collection,
`management, analysis, or interpretation of the data; or the preparation of the manuscript. Genentech
`provided the ranibizumab for the study, and Allergan, Inc., provided the triamcinolone for the study. In
`addition, Genentech and Allergan, Inc., provided funds to the DRCR.net to defray the study's clinical site
`costs. As described in the DRCR.net Industry Collaboration Guidelines (available at www.drcr.net), the
`DRCR.net had complete control over the design of the protocol, the ownership of the data, and all editorial
`
`https://www.aaojournal.org/article/S0161-6420(10)00243-5/fulltext
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`
`content of presentations and publications related to the protocol. A complete list of all DRCR.net investigator
`financial disclosures can be found at www.drcr.net.
`
`The lead author(s) have made the following disclosure(s): Scott M. Friedman: Sirion Therapeutics (S),
`MacuSight (S), Pfizer (S), Vitreoretinal Technologies (S), Allergan (S), EMMES Corporation (S). Ingrid U.
`Scott: Genentech (C). Lloyd P. Aiello: Genentech (C). Susan B. Bressler: GlaxoSmithKline (C). Frederick L.
`Ferris III; Bausch & Lomb (P).
`
`Neil M. Bressler:
`
`Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution
`(e.g., the School of Medicine) that receives the grants, typically through the Office of Research
`Administration. Individual investigators who participate in the sponsored project(s) are not directly
`compensated by the sponsor but may receive salary or other support from the institution to support their
`effort on the projects(s).
`
`Dr. Neil M. Bressler is Principal Investigator of grants at The Johns Hopkins University sponsored by the
`following entities (not including the National Institutes of Health): Allergan, Bausch & Lomb, Carl Zeiss
`Meditec, EMMES Corporation, Genentech, Lumenis, Notal Vision Ltd.,* Novartis, QLT, Regeneron, Steba
`Biotech, Abbott Medical Optics, ForSight Labs, LLC, and Genzyme Corporation. Dr. Susan B. Bressler's
`consulting arrangement with Notal Vision in connection with Dr. Neil M. Bressler's role as principal
`investigator on a Notal Vision-sponsored research grant has been reviewed and managed by The Johns
`Hopkins University School of Medicine in accordance with its conflict of interest policy.
`Identification
`DOI: https://doi.org/10.1016/j.ophtha.2010.02.031
`
`Copyright
`© 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
`ScienceDirect
`Access this article on ScienceDirect
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