Purpose-To report the incidence of endophthalmitis following intravitreal injection using a standardized injection procedure. Design-Two randomized clinical trialsMethods-Nonpreserved intravitreal triamcinolone acetonide in prefilled syringes (Allergan, Inc., Irvine, CA) was injected intravitreally in the Diabetic Retinopathy Clinical Research Network (DRCRnet) and the Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) clinical trials. The standardized injection procedure did not include the use of topical antibiotics during the days prior to the injection.Results-As of December 31, 2006, 1,378 intravitreal injections (538 eyes) have been administered in the DRCRnet DME trial and 631 injections (301 eyes) in SCORE. There was one case of endophthalmitis in the 2,009 injections to date (0.05%, 95% confidence interval 0.001% to 0.277%).Conclusions-A low rate of endophthalmitis is achievable using a standardized procedure for intravitreal injection without prescribing antibiotic prophylaxis on the days prior to the injection.Endophthalmitis is one of the most serious complications of intravitreal injection, with the reported risk per injection ranging from 0.1% to 1.6%. 1 Controversy exists with regard to the pre-injection ocular surface preparation, particularly the pre-injection use of topical antibiotics. Povidone iodine is the only substance proven to reduce the risk of endophthalmitis after intraocular surgery. 2 Although there may be a synergistic effect of topical antibiotics and topical povidone iodine in reducing the culture positive rate of the preoperative conjunctival surface, 3 topical antibiotics have never been shown to reduce the risk of endophthalmitis. 4 Nevertheless, some retinal surgeons prescribe topical antibiotics for several days prior to an intravitreal injection and several clinical trials have required this practice. 5,6 Herein, we report the endophthalmitis risk with the preparation and injection procedure used in the intravitreal triamcinolone protocols of the Diabetic Retinopathy Clinical Research Network (DRCRnet) and the Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) clinical trials.The DRCRnet and SCORE protocols use the same standardized procedure for the preparation and intravitreal injection procedure using preservative-free triamcinolone (1 mg or 4 mg) in Corresponding author: Adam R. Glassman, M.S., Jaeb Center for Health Research, 15310 Amberly Drive, #350, Tampa, FL 33647; phone 813-975-8690, fax 800-816-7601; email:aglassman@jaeb.org. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Publ...

Objective-To evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR). Main Outcome-Cumulative probability of vitrectomy within 16 weeks.Methods-Study eyes had VH from PDR precluding panretinal photocoagulation (PRP) completion. Eyes were randomly assigned to 0.5-mg ranibizumab (N = 125) or saline (N = 136) at baseline, 4, and 8 weeks.Results-Cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab versus 17% with saline (difference 4%, 95% confidence interval −4%-13%) and of complete PRP without vitrectomy by 16-weeks was 44% and 31% respectively (P = 0.05). The mean (±SD) visual acuity improvement from baseline to 12 weeks was 22±23 letters and 16±31 letters respectively (P = 0.04). Recurrent VH occurred within 16 weeks in 6% and 17% respectively (P = 0.01). One eye developed endophthalmitis after saline.Conclusions-Overall the 16 week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and * A published list of the Diabetic Retinopathy Clinical Research Network investigators and staff participating in this protocol can be found in Appendix 1 with a current list and financial disclosures available at www.drcr.net

Purpose Prioritizing comparative effectiveness research may contribute to obtaining answers that clinicians perceive they need and may minimize research that could be considered wasteful. Our objective was to identify evidence gaps and set priorities for new systematic reviews and randomized controlled trials for managing diabetic retinopathy (DR), including diabetic macular edema (DME). Design Cross-sectional study. Participants Diabetic Retinopathy Clinical Research Network (DRCR.net) investigators. Methods We provided recommendations from the American Academy of Ophthalmology’s 2012 Preferred Practice Patterns for Diabetic Retinopathy as 91 answerable clinical research questions about intervention effectiveness to 410 DRCR.net investigators to rate each question’s importance from 0 (not important) to 10 (very important) using a 2-round Delphi survey and to suggest additional questions. We considered questions as high priority if at least 75% of respondents to both rounds assigned an importance rating of 5 or more in round 2. We also extracted outcome measures relevant to DR and asked respondents to identify those that must be measured in all studies. We mapped Cochrane reviews published up to March 2016 to high-priority clinical research questions. Main Outcome Measure Ranking of importance of each clinical question. Results Thirty-two individuals completed rounds 1 and 2 and suggested 15 questions. Among the final list of 106 clinical research questions, 22 questions met our definition of high priority: 9 of 22 concerned the effectiveness of anti-VEGF therapy, and 13 of 22 focused on how often patients should be followed up (re-examination) and treatment effectiveness in patients with specific characteristics (e.g., DME). Outcomes that 75% or more of respondents marked as “must be measured in all studies” included visual acuity and visual loss, death of participants, and intraocular pressure. Only 1 prioritized question was associated with conclusive evidence from a Cochrane systematic review. Conclusions A limited response rate among DRCR.net members identified 22 comparative effectiveness research questions as high priority for the management of DR, including DME, but few were associated with Cochrane reviews. These results support the need of systematic reviews and randomized controlled trials to address evidence gaps.

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