Neil M Bressler

Johns Hopkins Medicine, Baltimore, Maryland, United States

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Publications (246)1007.78 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred (for ≥24 weeks) focal/grid laser treatment for diabetic macular edema (DME). Multicenter, randomized clinical trial. Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years, 124 (97%) and 111 (92%) completed the 5-year visit in the prompt and deferred groups, respectively. Random assignment to ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and prompt or deferred (≥24 weeks) focal/grid laser treatment. Best-corrected visual acuity at the 5-year visit. The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group (mean difference, -2.6 letters; 95% confidence interval, -5.5 to +0.4 letters; P = 0.09). At the 5-year visit in the prompt versus deferred laser groups, there was vision loss of ≥10 letters in 9% versus 8%, an improvement of ≥10 letters in 46% versus 58%, and an improvement of ≥15 letters in 27% versus 38% of participants, respectively. From baseline to 5 years, 56% of participants in the deferred group did not receive laser. The median number of injections was 13 versus 17 in the prompt and deferral groups, including 54% and 45% receiving no injections during year 4 and 62% and 52% receiving no injections during year 5, respectively. Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for ≥24 weeks in eyes with DME involving the central macula with vision impairment. Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years, such eyes may require more injections to achieve these results when following this protocol. Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
    Ophthalmology 10/2014; · 5.56 Impact Factor
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    ABSTRACT: Purpose To assess the development of vision-threatening lesions at least 3.5 years after initiating anti-vascular endothelial growth factor (VEGF) for choroidal neovascularization (CNV) in eyes with age-related macular degeneration (AMD). Design Retrospective cohort study. Participants A total of 75 patients (81 eyes) with CNV secondary to AMD who received intravitreous anti-VEGF treatment and were followed for at least 3.5 years after initiating treatment. Methods Retrospective record review of patients initiating anti-VEGF treatment between November 2005 and June 2008 at a university-based institution for whom at least 3.5 years of follow-up was available at the same institution. Main Outcome Measures Predominantly hemorrhagic lesions or geographic atrophy (GA). Results Among 75 patients (81 eyes; 59% were women; median age, 78 years), mean follow-up was 4.9 years and at least 6 years for 40%. Median visual acuity (VA) was 20/80 (interquartile range [IQR], 20/50–20/100) initially, 20/63 (IQR, 20/40–20/160) at 2 years, 20/80 (IQR, 20/40–20/200) at 3.5 years, and 20/63 (IQR 20/32–20/200) at 6 years. Six eyes (7%) had predominantly hemorrhagic lesions initially, whereas this developed in an additional 3 eyes (4%, 95% confidence interval [CI], 1% to 10%) in 3.5 years and in 1 additional eye (1%, 95% CI, 0.03% to 7%) at more than 3.5 years of follow-up. Initially, GA within or overlapping the boundary of the entire CNV was present in 4 eyes (5%) and outside this boundary in 8 eyes (10%). Geographic atrophy enlarged in each eye over time. The only eyes that developed GA outside the CNV boundary were those that had GA outside the lesion at baseline. Additional atrophy within the boundary of CNV defined at baseline, termed “atrophic disciform scars,” developed in 5 eyes (6%), all within 4 years of treatment initiation. Conclusions Longer-term follow-up of neovascular AMD managed with anti-VEGF therapy suggests that predominantly hemorrhagic lesions may develop within 3.5 years of initiating therapy and more than 3.5 years after initiating therapy. In contrast, new areas of GA beyond the boundaries of the CNV lesion as defined at initiation of anti-VEGF therapy seem unlikely to develop if there is no GA outside of the CNV lesion initially.
    Ophthalmology 10/2014; · 5.56 Impact Factor
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    ABSTRACT: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME).
    Ophthalmology 08/2014; · 5.56 Impact Factor
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    ABSTRACT: Diabetic macular edema (DME) is a leading cause of vision loss in persons with diabetes mellitus. Although there are national estimates for the prevalence of diabetic retinopathy and its risk factors among persons with diabetes, to our knowledge, no comparable estimates are available for DME specifically.
    Jama Ophthalmology 08/2014; · 3.83 Impact Factor
  • Neil M Bressler, Rohit Varma, Quan Doan
    Jama Ophthalmology 08/2014; 132(8):1030-1. · 3.83 Impact Factor
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    ABSTRACT: Understanding measurement variability and relationships between measurements obtained on different optical coherence tomography (OCT) machines is critical for clinical trials and clinical settings.
    Jama Ophthalmology 07/2014; · 3.83 Impact Factor
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    ABSTRACT: To evaluate the effects of 0.3 mg or 0.5 mg of ranibizumab in eyes with macular telangiectasia type 2 without subretinal neovascularization.
    Retina (Philadelphia, Pa.) 06/2014; · 2.93 Impact Factor
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    ABSTRACT: To describe clinical and imaging findings in two eyes with new onset subtle neovascular age-related macular degeneration that was detected by the regular use of a home monitoring device based on preferential hyperacuity visual field testing.
    Retinal Cases & Brief Reports 06/2014;
  • Lee M Jampol, Neil M Bressler, Adam R Glassman
    JAMA The Journal of the American Medical Association 06/2014; 311(22):2269-2270. · 29.98 Impact Factor
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    ABSTRACT: Purpose: Some clinical trials that proved the benefits of anti-VEGF therapy for diabetic macular edema (DME) based retreatment decisions on visual acuity and time-domain ocular coherence tomography (TD-OCT) central subfield thickness changes since the last treatment. This study assessed the impact of TD-OCT followed by spectral domain (SD)-OCT on as needed treatment decision-making in the management of DME with anti-VEGF medications. Methods: Patients previously treated for DME with anti-VEGF medications in the Retina Division of the Wilmer Eye Institute, following an IRB approved informed consent process, underwent clinical examination, TD- and SD-OCT imaging. Their retina specialists recorded whether additional anti-VEGF therapy was recommended and their level of certainty in the decision after performing a clinical examination and reviewing a TD-OCT, and then again after reviewing a SD-OCT. Results: Data were collected for 129 treatment decision pairs involving 67 eyes from 46 subjects. Non-concordant decisions occurred in 9 (7%) treatment decision pairs. In 7 of these (5%, 95% confidence interval [CI]: 2% to 11%), the addition of SD-OCT changed the retina specialist's decision from not recommending to recommending retreatment. The addition of SD-OCT increased the certainty of the retina specialist in 36% (95% CI: 27% to 45%) of all treatment decision pairs. Conclusions: SD-OCT does not appear to change the ultimate treatment decision or increase the level of certainty of the retina specialist relative to TD-OCT in most cases of DME under anti-VEGF management in clinical practice. The few non-concordant decisions appear to trend towards recommending more anti-VEGF therapy following SD-OCT.
    Investigative ophthalmology & visual science 02/2014; · 3.43 Impact Factor
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    ABSTRACT: IMPORTANCE Understanding how individuals value health states is central to patient-centered care and to health policy decision making. Generic preference-based measures of health may not effectively capture the impact of ocular diseases. Recently, 6 items from the National Eye Institute Visual Function Questionnaire-25 were used to develop the Visual Function Questionnaire-Utility Index health state classification, which defines visual function health states. OBJECTIVE To describe elicitation of preferences for health states generated from the Visual Function Questionnaire-Utility Index health state classification and development of an algorithm to estimate health preference scores for any health state. DESIGN, SETTING, AND PARTICIPANTS Nonintervention, cross-sectional study of the general community in 4 countries (Australia, Canada, United Kingdom, and United States). A total of 607 adult participants were recruited from local newspaper advertisements. In the United Kingdom, an existing database of participants from previous studies was used for recruitment. INTERVENTIONS Eight of 15 625 possible health states from the Visual Function Questionnaire-Utility Index were valued using time trade-off technique. MAIN OUTCOMES AND MEASURES A θ severity score was calculated for Visual Function Questionnaire-Utility Index-defined health states using item response theory analysis. Regression models were then used to develop an algorithm to assign health state preference values for all potential health states defined by the Visual Function Questionnaire-Utility Index. RESULTS Health state preference values for the 8 states ranged from a mean (SD) of 0.343 (0.395) to 0.956 (0.124). As expected, preference values declined with worsening visual function. Results indicate that the Visual Function Questionnaire-Utility Index describes states that participants view as spanning most of the continuum from full health to dead. CONCLUSIONS AND RELEVANCE Visual Function Questionnaire-Utility Index health state classification produces health preference scores that can be estimated in vision-related studies that include the National Eye Institute Visual Function Questionnaire-25. These preference scores may be of value for estimating utilities in economic and health policy analyses.
    Jama Ophthalmology 01/2014; · 3.83 Impact Factor
  • Neil M Bressler, Roy W Beck, Michael A Kass
    Jama Ophthalmology 01/2014; 132(1):11-2. · 3.83 Impact Factor
  • Voraporn Chaikitmongkol, Neil M Bressler
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    ABSTRACT: To describe the clinical and optical coherence tomography findings of an eye with diabetic macular edema that developed intraretinal fibrosis in an area previously occupied by lipid accumulating after the intravitreous ranibizumab treatment.
    Retinal Cases & Brief Reports 01/2014; 8(4):336-9.
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    ABSTRACT: Intravitreal injections of anti-vascular endothelial growth factor agents, such as ranibizumab, have significantly improved the management of neovascular age-related macular degeneration. This study used patient-level simulation modelling to estimate the number of individuals in Australia who would have been likely to avoid legal blindness or visual impairment due to neovascular age-related macular degeneration over a 2-year period as a result of intravitreal ranibizumab injections. The modelling approach used existing data for the incidence of neovascular age-related macular degeneration in Australia and outcomes from ranibizumab trials. Blindness and visual impairment were defined as visual acuity in the better-seeing eye of worse than 6/60 or 6/12, respectively. In 2010, 14 634 individuals in Australia were estimated to develop neovascular age-related macular degeneration who would be eligible for ranibizumab therapy. Without treatment, 2246 individuals would become legally blind over 2 years. Monthly 0.5 mg intravitreal ranibizumab would reduce incident blindness by 72% (95% simulation interval, 70-74%). Ranibizumab given as needed would reduce incident blindness by 68% (64-71%). Without treatment, 4846 individuals would become visually impaired over 2 years; this proportion would be reduced by 37% (34-39%) with monthly intravitreal ranibizumab, and by 28% (23-33%) with ranibizumab given as needed. These data suggest that intravitreal injections of ranibizumab, given either monthly or as needed, can substantially lower the number of cases of blindness and visual impairment over 2 years after the diagnosis of neovascular age-related macular degeneration.
    PLoS ONE 01/2014; 9(6):e101072. · 3.53 Impact Factor
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    ABSTRACT: IMPORTANCE Thickening of the center of the retina, diabetic macular edema (DME), is the most common cause of visual loss due to diabetes mellitus. Treatment of DME has improved dramatically, and the prompt diagnosis of DME and referral of these patients have become more critical. Nonetheless, awareness of and care for DME in the US population is uncharacterized. OBJECTIVE To characterize eye care and awareness of eye disease among persons with DME in the general US population. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional analysis of data from participants in the 2005 to 2008 National Health and Nutrition Examination Survey 40 years or older with diabetes mellitus and fundus photographs. MAIN OUTCOMES AND MEASURES Among persons with DME, (1) awareness that diabetes has affected their eyes; (2) report on the last time they visited a diabetes specialist; (3) report on their last eye examination with pupil dilation; and (4) prevalence of visual impairment. RESULTS In 2010, only 44.7% (95% CI, 27.0%-62.4%) of US adults 40 years or older with DME reported being told by a physician that diabetes had affected their eyes or that they had retinopathy; 46.7% (95% CI, 27.5%-66.0%), that they had visited a diabetes nurse educator, dietician, or nutritionist for their diabetes mellitus more than 1 year ago or never; and 59.7% (95% CI, 43.5%-75.9%), that they had received an eye examination with pupil dilation in the last year. Among persons with DME, 28.7% (95% CI, 12.7%-44.7%) were visually impaired (defined as visual acuity worse than 20/40 in the eye with DME) based on visual acuity at the initial examination and 16.0% (95% CI, 2.5%-29.4%) based on best-corrected visual acuity. CONCLUSIONS AND RELEVANCE Many persons with diabetes mellitus in the United States are not getting care that can prevent visual impairment and blindness. Strategies to increase awareness are warranted, especially given the recent availability of improved therapies for DME.
    Jama Ophthalmology 12/2013; · 3.83 Impact Factor
  • Jama Ophthalmology 12/2013; · 3.83 Impact Factor
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    ABSTRACT: IMPORTANCE Few data are available on relative changes in vision-related function after treatment for diabetic macular edema (DME). OBJECTIVE To determine the impact of intravitreal ranibizumab, 0.5 mg, compared with laser on patient-reported visual function. DESIGN Phase 3, randomized, double-masked, 12-month study. SETTING Outpatient retina practices in Australia, Canada, and Europe. PARTICIPANTS Patients 18 years or older with type 1 or 2 diabetes mellitus and visual impairment due to DME. INTERVENTIONS Patients were randomized to ranibizumab plus sham laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus laser (n = 111). Ranibizumab and sham injections were given for 3 consecutive months then as needed; laser plus sham laser treatment was given at baseline then as needed. MAIN OUTCOMES AND MEASURES National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) scores at 0, 3, and 12 months for patients receiving 1 or more study treatments with 1 or more postbaseline NEI VFQ-25 assessments and last observation carried forward for missing data. RESULTS Mean baseline NEI VFQ-25 composite scores were 72.8, 73.5, and 74.1 in the ranibizumab, laser, and ranibizumab plus laser groups, respectively. At 12 months, the mean composite scores (95% CIs) improved by 5.0 (ranibizumab vs laser, 2.6 to 7.4; P = .01 vs laser) and 5.4 (ranibizumab plus laser vs laser alone, 3.3 to 7.4; P = .004 vs laser) from baseline in the ranibizumab and ranibizumab plus laser groups, respectively, compared with 0.6 (-1.8 to 3.0) for the laser group. Near activities scores improved by 9.0 (ranibizumab vs laser, 5.0 to 13.0; P = .01) and 9.1 (ranibizumab plus laser vs laser, 5.6 to 12.6; P = .006) compared with 1.1 (-3.0 to 5.2) for the laser group, whereas distance activities scores improved by 5.3 (ranibizumab vs laser, 1.8 to 8.9; P = .04) and 5.6 (ranibizumab plus laser vs laser, 2.3 to 9.0; P = .03) compared with 0.4 (-3.1 to 3.8) for the laser group. Patients with better baseline visual acuity or lower central retinal thickness had greater improvements with ranibizumab treatment compared with laser in composite and some subscale scores compared with patients with worse visual acuity or higher central retinal thickness. CONCLUSIONS AND RELEVANCE These data provide vision-related, patient-reported outcome evidence that mirrors visual acuity outcomes and supports benefits from ranibizumab or ranibizumab plus laser treatment for patients with DME and characteristics similar to those enrolled in this randomized clinical trial. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00687804.
    Jama Ophthalmology 08/2013; · 3.83 Impact Factor
  • Neil M Bressler
    Jama Ophthalmology 07/2013; 131(7):839. · 3.83 Impact Factor
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    ABSTRACT: Explore differences in green compared with yellow focal/grid laser treatment on functional and anatomical endpoints in eyes with diabetic macular edema. Data from two randomized clinical trials were evaluated for differences in visual acuity and optical coherence tomography parameters for eyes assigned to sham injection + prompt laser, ranibizumab + prompt laser, or prompt laser only: among subgroups of eyes treated exclusively and electively with either green or yellow laser. In the sham injection + prompt laser group, the mean visual acuity letter score change for eyes receiving green and yellow laser treatment, respectively, was +2.4 ± 14 and +5.1 ± 13 at the 52-week visit (P = 0.06) and +2.4 ± 15 and +6.0 ± 13 at the 104-week visit (P = 0.13), with no corresponding evidence of differences in optical coherence tomography thickness. When comparing wavelength groups in the ranibizumab + prompt laser and prompt laser-only groups, meaningful differences in visual acuity and optical coherence tomography thickness were not detected at 1 year or 2 years. A trend toward improved vision outcome with yellow laser observed in one trial was not corroborated by anatomical outcomes or by the other trial. In this study, without random assignment to different wavelengths controlling for bias and confounding, it is not possible to determine whether one wavelength is better than the other.
    Retina (Philadelphia, Pa.) 06/2013; · 2.93 Impact Factor
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    ABSTRACT: IMPORTANCE Treatment of macular edema secondary to retinal vein occlusion with ranibizumab has been shown to improve visual acuity compared with macular laser or observation. It is important to determine whether these visual acuity improvements translate into measurable improvements in visual function. OBJECTIVE To examine the benefit of ranibizumab (Lucentis) on measured reading speed, a direct performance assessment, through 6 months in eyes of patients with macular edema after retinal vein occlusion (RVO). DESIGN Two multicenter, double-masked, phase 3 trials in which participants with macular edema after branch RVO or central RVO were randomized 1:1:1 to monthly sham, ranibizumab, 0.3 mg, or ranibizumab, 0.5 mg, for 6 months. SETTING Community- and academic-based ophthalmology practices specializing in retinal diseases. PARTICIPANTS Seven hundred eighty-nine eyes of 789 participants who were at least aged 18 years with macular edema secondary to retinal vein occlusion in the branch vein occlusion (BRAVO) and central vein occlusion (CRUISE) trials. INTERVENTIONS Eyes were randomized 1:1:1 to 1 of 3 groups for monthly injections for 6 months: sham (132 in BRAVO and 130 in CRUISE), intravitreal ranibizumab, 0.3 mg (134 in BRAVO and 132 in CRUISE), and intravitreal ranibizumab, 0.5 mg (131 in BRAVO and 130 in CRUISE). Patients were able to receive macular laser after 3 months if they met prespecified criteria. MAIN OUTCOMES AND MEASURES Reading speed in the study eye was measured with enlarged text (letter size equivalent to approximately 20/1500 at the test distance) at baseline and 1, 3, and 6 months. The number of correctly read words per minute (wpm) was reported. The reading speed test requires a sixth-grade reading level and does not account for literacy or cognitive state. RESULTS In patients with branch RVO, the mean gain for the 0.5-mg group was 31.3 wpm compared with 15.0 wpm in sham-treated eyes (difference, 16.3 wpm; P = .007) at 6 months. In patients with central RVO, the mean gain for the 0.5-mg group was 20.5 wpm compared with 8.1 wpm in sham-treated eyes (difference, 12.4 wpm; P = .01) at 6 months. A gain of 15 or more letters of best-corrected visual acuity letter score corresponded to an increase in reading speed of 12.3 wpm and 15.8 wpm in patients with branch and central RVO, respectively. CONCLUSIONS AND RELEVANCE These results suggest that patients with macular edema after RVO treated monthly with ranibizumab are more likely to have improvements in reading speed of the affected eyes through 6 months compared with sham treatment. These results demonstrate the relevance of the treatment benefit to functional visual gain. TRIAL REGISTRATION clinicaltrials.gov Identifier:NCT00486018 and NCT00485836.
    Jama Ophthalmology 05/2013; · 3.83 Impact Factor

Publication Stats

8k Citations
1,007.78 Total Impact Points

Institutions

  • 1989–2014
    • Johns Hopkins Medicine
      • • Wilmer Eye Institute
      • • Department of Pathology
      Baltimore, Maryland, United States
  • 1988–2014
    • Johns Hopkins University
      • • Wilmer Eye Institute
      • • Applied Physics Laboratory
      Baltimore, Maryland, United States
  • 2010–2012
    • University of Southern California
      • Doheny Eye Institute
      Los Angeles, CA, United States
    • Oregon Health and Science University
      Portland, Oregon, United States
  • 2007–2012
    • Jaeb Center for Health Research
      Tampa, Florida, United States
  • 1999–2010
    • University of Maryland, Baltimore
      Baltimore, Maryland, United States
    • Harvard Medical School
      Boston, Massachusetts, United States
  • 1997–2010
    • University of Wisconsin, Madison
      • Department of Ophthalmology and Visual Sciences
      Madison, MS, United States
  • 2009
    • Stony Brook University
      • Department of Preventive Medicine
      Stony Brook, NY, United States
    • Retina Associates of Florida
      Tampa, Florida, United States
    • Vanderbilt University
      Nashville, Michigan, United States
    • Penn State Hershey Medical Center and Penn State College of Medicine
      Hershey, Pennsylvania, United States
  • 2008
    • Hospital of the University of Pennsylvania
      Philadelphia, Pennsylvania, United States
  • 2007–2008
    • Greater Baltimore Medical Center
      Baltimore, Maryland, United States
  • 2005
    • Emory University
      • Department of Ophthalmology
      Atlanta, Georgia, United States
    • Doheny Eye Institute
      Los Angeles, California, United States
  • 2002
    • University College London
      • Institute of Ophthalmology
      London, ENG, United Kingdom
  • 2001
    • Université Paris-Est Créteil Val de Marne - Université Paris 12
      Créteil, Île-de-France, France
  • 1998
    • Universität zu Lübeck
      Lübeck Hansestadt, Schleswig-Holstein, Germany
  • 1996
    • University of California, Santa Barbara
      • Neuroscience Research Institute
      Santa Barbara, CA, United States
  • 1992
    • University of Melbourne
      • Department of Ophthalmology
      Melbourne, Victoria, Australia