Objective To report expanded 2-year follow up of a previously reported randomized trial evaluating 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 Eight hundred and fifty four study eyes of 691 participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Methods Continuation of procedures previously reported for the randomized trial. Main Outcome Measures Best-corrected visual acuity and safety at the 2-year visit. Results At the 2-year visit, compared with the sham plus prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab plus prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI]: -0.4 to +7.7) l, 5.8 letters greater in the ranibizumab plus deferred laser group (95% aCI: +1.9 to +9.8) and 1.5 letters worse in the triamcinolone plus prompt laser group (95% aCI : -5.5 to +2.4). After the 1- through the 2-year visit in the ranibizumab with prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab + prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the triamcinolone + prompt laser group. No systemic events attributable to study treatment were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis in the ranibizumab groups while elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone+prompt laser group. Conclusions The expanded 2-year results reported herein are similar to results published previously and reinforce the conclusions originally reported, that ranibizumab should be considered for patients with DME and characteristics similar to the cohort in this clinical trial, including vision impairment with DME involving the center of the macula.

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Objective To report 3-year follow-up within a previously reported randomized trial evaluating prompt versus deferred (for ≥24 weeks) focal/grid laser treatment in eyes treated with intravitreal 0.5-mg ranibizumab for diabetic macular edema (DME). Design Multicenter randomized clinical trial. Participants Three hundred and sixty one participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Methods Ranibizumab every four weeks until no longer improving (with resumption if worsening) and random assignment to focal/grid laser treatment promptly or deferred (≥24 weeks). Main Outcome Measures Best-corrected visual acuity and safety at the 156-week (“3-year”) visit. Results The estimated mean change in visual acuity letter score from baseline through the 3-year visit was 2.9 letters greater (9.7 versus 6.8, mean difference = 2.9, 95% confidence interval 0.4 to 5.4, P = 0.02) in the deferral group compared with the prompt laser treatment group. In the prompt laser treatment group and deferral group, respectively, the percentage of eyes with a ≥10 letter gain was 42% and 56% (P = 0.02), while the percentage of eyes with a ≥10 letter loss was 10% and 5% (P = 0.12). Up to the 3-year visit, the median numbers of injections were 12 and 15 in the prompt and deferral groups, respectively (P = 0.007), including 1 and 2, respectively, from the 2- up to the 3-year visit. At the 3-year visit, the percentages of eyes with central subfield thickness ≥250 μm on time domain optical coherence tomography were 36% in both groups (P = 0.90). In the deferral group, 54% did not receive laser treatment during the trial. Systemic adverse events appeared similar in the two groups. Conclusions These 3-year results suggest that focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better, and possibly worse for vision outcomes, than deferring laser treatment for ≥ 24 weeks in eyes with DME involving the fovea and with vision impairment. Some of the observed difference in visual acuity at three years may be related to fewer cumulative ranibizumab injections during follow-up in the prompt laser treatment group. Follow-up through five years continues.

Objective-To evaluate optical coherence tomography (OCT) measurements and methods of analysis of OCT data in studies of diabetic macular edema (DME).Design-Associations of pairs of OCT variables and results of three analysis methods using data from two studies of DME.Participants-Two hundred sixty-three subjects from a study of modified Early Treatment of Diabetic Retinopathy Study (mETDRS) versus modified macular grid (MMG) photocoagulation for DME and 96 subjects from a study of diurnal variation of DME.Methods-Correlations were calculated for pairs of OCT variables at baseline and for changes in the variables over time. Distribution of OCT measurement changes, predictive factors for OCT measurement changes, and treatment group outcomes were compared when three measures of change in macular thickness were analyzed: absolute change in retinal thickness, relative change in retinal thickness, and relative change in retinal thickening. Main Outcome Measures-Concordance of results using different OCT variables and analysis methods.Results-Center point thickness correlated highly with central subfield mean thickness (CSMT) at baseline (0.98-0.99). The distributions of changes in CSMT were approximately normally distributed for absolute change in retinal thickness and relative change in retinal thickness, but not for relative change in retinal thickening. The macular thinning in the mETDRS group was significantly greater than in the MMG group when absolute change in retinal thickness was used, but not when relative change in thickness and relative change in thickening were used. Relative Fax: (800) 816-7601, drcrnetX1@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.A current list of the Diabetic Retinopathy Clinical Research Network is available at www.drcr.net DRCRnet investigator financial disclosures are posted at www.drcr.netThere are no conflicts of interest. PrécisFor a macula with marked edema, relative change in thickening may be the preferred method of optical coherence tomography analysis, whereas for a macula with mild edema, absolute change in retinal thickness may be preferable. In the current report we address these topics with reference to diabetic macular edema (DME), and not other conditions, based on experience with analyzing over 16,000 scans with OCT in clinical research protocols over four years. NIH Public Access MethodsThe specific objectives of this report are as follows:1. To identify the optimal OCT measurement for central macular thickening in DME 2. To identify roles for paracentral and global macular OCT measurements and explor...

We evaluated a Veterans Health Administration (VHA) care coordination/ home-telehealth (CC/HT) program on the utilization of health care services and health-related quality of life (HRQL) in veterans with diabetes. Administrative records of 445 veterans with diabetes were reviewed to compare health care service utilization in the 1-year period before and 1-year period post-enrollment and also examined self-reported HRQL at enrollment and 1 year later. Multivariate analyses indicated a statistically significant reduction in the proportion of patients who were hospitalized (50% reduction), emergency room use (11% reduction), reduction in the average number of bed days of care (decreased an average of 3.0 days), and improvement in the HRQL role-physical functioning, bodily pain, and social functioning. The results need to be interpreted with caution because we used a single-group study design that may be influenced by regression to the mean. Ideally, future research should use a randomized controlled trial design.