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Endophthalmitis associated with intravitreal anti-vascular endothelial growth factor therapy injections in an office setting [Case Report]
Pilli, Suman; Kotsolis, Athanasios; Spaide, Richard F; Slakter, Jason; Freund, K Bailey; Sorenson, John; Klancnik, James; Cooney, Michael
PURPOSE: To determine the incidence of endophthalmitis following intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents. DESIGN: A retrospective interventional case series. METHODS: A total of 10,254 intravitreal anti-VEGF injections (406 pegaptanib, 3,501 bevacizumab, and 6,347 ranibizumab) were performed from January 5, 2005 to October 18, 2007. The number of the injections was determined from the injection log books and billing records. The injections were performed as an office based procedure with use of povidone-iodine as a part of preinjection preparation. Preinjection antibiotics, eye drape, or surgical attire were not used. The main outcome measures were the incidence of suspected and proven endophthalmitis. RESULTS: There were three cases of suspected endophthalmitis, one case following bevacizumab injection and two cases following ranibizumab injection. There was no case of culture-proven endophthalmitis. All three patients regained their preinjection visual acuity. The incidence of suspected endophthalmitis was 0.029% (95% confidence interval, 0.006% to 0.085%). There was no difference in the incidence of endophthalmitis between ranibizumab and bevacizumab injections (P = .6). CONCLUSIONS: Although there is no consensus regarding the intravitreal injection procedure technique, the incidence of suspected endophthalmitis was very low in a large series of injected patients in a community setting and the incidence compares favorably with that reported in clinical trials where much more extensive preinjection preparation was mandated. We found no difference in the endophthalmitis risk of patients receiving bevacizumab as compared with ranibizumab
PMID: 18329624
ISSN: 0002-9394
CID: 94829
Untitled - Reply [Letter]
Koizumi, H; Slakter, J; Spaide, R
ISI:000252370000031
ISSN: 0275-004x
CID: 103610
Verteporfin therapy of subfoveal occult choroidal neovascularization in AMD using delayed light application: one-year results of the VALIO Study
Rosenfeld, Philip J; Boyer, David S; Bressler, Neil M; Fish, Gary; Grizzard, W Sanderson; Hao, Yong; Hnik, Peter; Hudson, Henry L; Singerman, Lawrence; Slakter, Jason S
PURPOSE: To compare photodynamic therapy (PDT) with verteporfin (Visudyne; Novartis Pharma AG, Basel, Switzerland) using either standard or delayed light application. DESIGN: Phase II, multicenter, masked, randomized clinical trial. METHODS: Sixty patients with occult with no classic choroidal neovascularization (CNV) resulting from age-related macular degeneration were assigned randomly (1:1) to verteporfin infusion followed by light application either at 15 minutes (standard light) or 30 minutes (delayed light) after the start of the infusion. The assigned treatment was repeated every three months if fluorescein leakage was detected. RESULTS: At month 12, patients lost a mean of 15.7 letters and 11.4 letters from baseline in the standard and delayed light groups, respectively (P = .38). Twelve (52%) of 23 patients in the standard light group and 11 (42%) of 26 in the delayed light group lost at least 15 letters of visual acuity (P = .57). CONCLUSIONS: There were no statistically significant differences between verteporfin therapy using the delayed light regimen of 30 minutes or the standard light regimen of 15 minutes in eyes with occult with no classic CNV
PMID: 18036873
ISSN: 0002-9394
CID: 94786
Ranibizumab for treatment of choroidal neovascularization secondary to age-related macular degeneration
Bhatnagar, Pawan; Spaide, Richard F; Takahashi, Beatriz S; Peragallo, Jason H; Freund, K Bailey; Klancnik, James M Jr; Cooney, Michael J; Slakter, Jason S; Sorenson, John A; Yannuzzi, Lawrence A
PURPOSE: To evaluate the short-term outcomes after intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) injection in patients with neovascular age-related macular degeneration. METHODS: A review of data for consecutive patients who received intravitreal ranibizumab injection was conducted. The main outcome measures were mean visual acuity and central macular thickness at 3 months compared with those at baseline. Response to ranibizumab therapy was evaluated with particular attention to prior treatment with bevacizumab (Avastin; Genentech, Inc.). RESULTS: Mean baseline visual acuity of 231 eyes of 231 patients was 20/152, and 189 patients (81.8%) had undergone prior treatment, with 153 (65.4%) having received intravitreal bevacizumab. Mean visual acuity at 3 months, available for 203 patients (88%), was 20/126 (P = 0.004). Mean visual acuity for 98 patients treated with bevacizumab within 3 months before ranibizumab injection was 20/100 at baseline and 20/98 at 3 months (P = 0.35). Mean baseline central macular thickness was 278 microm for all patients and improved to 211 microm at 3 months (P < 0.001). Macular thickness decrease was noted irrespective of previous bevacizumab therapy. CONCLUSION: Ranibizumab therapy was associated with significant improvements in mean visual acuity and central macular thickness for the group of all patients. Patients who had received bevacizumab treatment within 3 months before initiating ranibizumab treatment had stability of, but no improvement in, visual acuity
PMID: 17891007
ISSN: 0275-004x
CID: 94076
Selective photodynamic therapy for neovascular age-related macular degeneration with polypoidal choroidal neovascularization
Eandi, Chiara M; Ober, Michael D; Freund, K Bailey; Slakter, Jason S; Yannuzzi, Lawrence A
PURPOSE: To evaluate the efficacy of selective treatment with indocyanine green (ICG) angiography-guided photodynamic therapy (PDT) with verteporfin for polypoidal choroidal vasculopathy (PCV). METHODS: In this retrospective consecutive series, 30 eyes of 30 patients with PCV were included. Complete ocular examination, digital fluorescein angiography (FA), ICG angiography, and optical coherence tomography were performed at baseline and at standard intervals thereafter. ICG angiography-guided PDT was performed on all eyes. Only the area of the active PCV or 'hot spot' evident on the ICG angiogram was treated. A spot size was chosen to cover the active neovascular lesion with a 200-mum border. Retreatment was performed when angiography revealed a recurrent lesion. RESULTS: Thirty eyes with PCV were treated and followed for 1 year. Mean age of the patients was 75 years (range, 55-90 years). These patients were all classified as having occult choroidal neovascularization (CNV) with FA and polypoidal CNV with ICG angiography. Improvement of vision (>or=3 lines) was achieved in 15 eyes (50%). Nine eyes had stable vision (30%), and 6 eyes (20%) had a decrease in vision (>or=3 lines). Repeated treatment was required in 15 eyes (50%) for an average of 2.2 treatments in 1 year. CONCLUSION: This study indicates that stabilization or improvement of vision is achieved in most eyes (80%) with neovascular AMD from PCV after selected ICG angiography-guided PDT. These outcomes compare very favorably with those in previous reports on the treatment of occult CNV. Reduced collateral damage to the choriocapillaris and reduced upregulation of vascular endothelial growth factor are presumed to be the explanation for this apparently better outcome. Further studies with longer follow-up are warranted to investigate the long-term efficacy in these conditions
PMID: 17891004
ISSN: 0275-004x
CID: 94077
Diagnostic and therapeutic challenges [Case Report]
Reddy, Shatan; Slakter, Jason; Aaberg, Thomas M Jr; Singh, Rishi P; Kaiser, Peter K
PMID: 17558329
ISSN: 0275-004x
CID: 73116
Full-thickness macular hole formation in idiopathic parafoveal telangiectasis [Case Report]
Koizumi, Hideki; Slakter, Jason S; Spaide, Richard F
PURPOSE: To describe the macular holes in patients with idiopathic parafoveal telangiectasis (IPT) and to propose a pathophysiologic explanation for their formation. METHODS: Four eyes of two patients with IPT were evaluated with biomicroscopy and optical coherence tomography (OCT). RESULTS: One patient had a nearly full-thickness hole with preservation of only the internal limiting membrane (ILM), but had a 20/60 visual acuity. The other patient had a large full-thickness macular hole, but retained 20/40 visual acuity. Each patient had a fellow eye showing prominent central inner foveal cavitation under a very thin ILM, which was devoid of associated tissue. CONCLUSIONS: This report describes the findings of two patients with IPT who developed pronounced central foveal structural abnormalities. The induced anatomic changes noted in our patients suggest that there is a loss of the structural aspects afforded by Muller cells, particularly the Muller cell cone, in the central macula in patients with IPT. The preservation of good visual acuity in our patients implies that the holes were the result of lateral separation of the photoreceptors within the fovea and that there could not have been profound atrophy of the photoreceptors
PMID: 17420701
ISSN: 0275-004x
CID: 94787
Intravitreal bevacizumab (Avastin) for retinal angiomatous proliferation [Case Report]
Meyerle, Catherine B; Freund, K Bailey; Iturralde, Diana; Spaide, Richard F; Sorenson, John A; Slakter, Jason S; Klancnik, James M Jr; Fisher, Yale L; Cooney, Michael J; Yannuzzi, Lawrence A
OBJECTIVE: To evaluate the short-term visual acuity and anatomic responses after intravitreal bevacizumab (Avastin, Genentech) treatment in patients with retinal angiomatous proliferation (RAP). METHODS: The authors conducted a retrospective review of consecutive patients with newly diagnosed or recurrent RAP treated with intravitreal bevacizumab (1.25 mg) during a 3-month period. Complete ocular examination was performed at baseline and follow-up visits. Interval data were analyzed statistically at 1 and 3 months follow-up. RESULTS: Twenty-three eyes of 23 patients underwent intravitreal bevacizumab treatment. The mean age of patients was 81.1 years, median baseline visual acuity of treated eyes was 20/80 (range 20/25-20/800), and mean baseline central macular thickness was 335 mum (optical coherence tomography was available for 22 eyes). Nine eyes had retinal pigment epithelial detachments (PEDs) at baseline. At 1-month follow-up, the median acuity improved to 20/60 (range 20/30-20/400) (P < 0.001), mean central macular thickness decreased to 202 microm (P < 0.001), and PED was present in only 2 eyes (P = 0.016). Seven of 23 eyes at 1 month (30.4%) had improved visual acuity, defined as halving of the visual angle, and no eyes had worse acuity, defined as doubling of the visual angle. Of the 17 eyes available for 3-month follow-up, 5 eyes (29.4%) had better visual acuity, 1 eye (5.9%) had worse acuity, and the remaining 11 (64.7%) had the same acuity. The median visual acuity at month 3 was 20/60 (range 20/25-20/400). There were no thromboembolic phenomena, endophthalmitis cases, retinal detachments, or any other adverse events. CONCLUSION: Treatment of RAP with intravitreal bevacizumab during this retrospective review resulted in a significant decrease in macular thickness and improvement or stabilization of visual acuity. Further long-term investigation is warranted given the promising short-term results
PMID: 17420697
ISSN: 0275-004x
CID: 94788
The Digital Angiography Reading Center (DARC) role in the anecortave acetate clinical trials
Slakter, Jason S; Carvalho, Cynthia; Coleman, Hannah
Advances in digital camera and computer technology have resulted in imaging systems providing clinically relevant information equivalent to traditional film-based techniques. The Digital Angiography Reading Center (DARC) was created to provide the next generation in reading center assessment for clinical trials of retinal disease. A fully digital angiographic imaging protocol was implemented with the anecortave acetate clinical studies. For image evaluation readers followed a standard manual of definitions and guidelines. Eligibility was determined based on protocol specific criteria. Rapid communication of images between the study sites and DARC permitted screening for eligibility and pre-treatment stratification of all patients prior to enrollment. This screening process was designed to eliminate angiographically ineligible patients from the clinical trials. The result was a reduction in the total number of patients needed to obtain sufficient evaluable patients for statistical assessment of treatment outcome. Digital angiography can be successfully used in clinical trials for retinal disease
PMID: 17240261
ISSN: 0039-6257
CID: 94789
The nature and frequency of neovascular age-related macular degeneration
Iranmanesh, R; Eandi, C M; Peiretti, E; Klais, C M; Garuti, S; Goldberg, D E; Slakter, J S; Yannuzzi, L A
PURPOSE: This study was designed to evaluate the frequency and nature of neovascularization in age-related macular degeneration (ARMD) utilizing the combination of digital imaging techniques, fluorescein angiography (FA), indocyanine green (ICG) angiography, and optical coherence tomography (OCT). METHODS: A complete clinical examination was performed on 100 eyes of 93 consecutive newly diagnosed patients with neovascular ARMD. Digital fluorescein angiography, ICG angiography, and OCT were also used in evaluating those patients. Comparison of the imaging techniques to determine their value in studying the nature of the lesions. RESULTS: On the basis of existing fluorescein standards, 15 eyes were diagnosed with classic choroidal neovascularization (CNV), 15 with minimally classic CNV, and 70 with occult CNV. ICG angiography was superior for detecting the active vascular component in polypoidal CNV (16 eyes) and retinal angiomatous proliferation (14 eyes). OCT was more sensitive than FA for determining the presence of cystoid macular edema evident in the vast majority of eyes with retinal angiomatous proliferation (RAP). CONCLUSIONS: These results suggest that FA, ICG angiography, and OCT, when used in combination, will assist clinicians in best determining the precise nature of the neovascular process in ARMD
PMID: 17294386
ISSN: 1120-6721
CID: 103383