Davis J.,Bascom Palmer Eye Institute |
Olsen T.W.,Emory University |
Sternberg Jr. P.,Vanderbilt University
American Journal of Ophthalmology | Year: 2011
Purpose: To provide a perspective on the impact of the Comparison of Age-related Macular Degeneration Treatments Trial (CATT) on future clinical practices. Design: Interpretation of trial outcomes relative to clinical use of neovascular age-related macular degeneration (AMD) treatments, assessment of the influence of study design and execution on results, and review of unanalyzed safety data in the online supplement. Methods: Expert opinion. Results: The CATT study supports the selection of either ranibizumab or bevacizumab for treatment of AMD based on factors other than efficacy, such as cost, because monthly administration of bevacizumab was noninferior to the reference treatment of monthly ranibizumab in improving visual acuity at 1 year. Visual acuity results for bevacizumab as needed were inconclusive for noninferiority relative to monthly administration of either drug. The secondary outcome of decrease in thickness at the foveal center as measured by time-domain optical coherence tomography significantly favored the monthly ranibizumab group vs the bevacizumab-as-needed group but is more difficult to interpret as it did not correlate with visual acuity and is less appropriate for a noninferiority design. Bevacizumab groups had a statistically higher observed risk of serious adverse events; however, scrutiny of the online supplements shows similar numbers of cardiac and neurologic events in bevacizumab and ranibizumab users. Information regarding fellow eye treatment with anti-VEGF agents was not given. Conclusions: CATT provides the first level I evidence for bevacizumab in a large number of patients with neovascular AMD. The trial supports use of either drug as primary therapy and suggests that modification of monthly dosing regimens is feasible. A difference in cardiovascular safety between the 2 drugs was not apparent on inspection of the supplementary safety data. © 2011 Elsevier Inc.
Browning D.J.,NC Associates |
Kaiser P.K.,Cleveland Clinic |
Rosenfeld P.J.,Bascom Palmer Eye Institute
American Journal of Ophthalmology | Year: 2012
• PURPOSE: To describe the pharmacokinetics, preclinical studies, and clinical trials of the newly approved anti-vascular endothelial growth factor (VEGF) drug aflibercept (Eylea (VEGF Trap-Eye); Regeneron; and Bayer). • DESIGN: Review with editorial commentary. • METHODS: A review of the medical literature and pertinent Internet postings combined with analysis of key studies with expert opinion regarding the use of aflibercept for the treatment of exudative age-related macular degeneration. • RESULTS: Aflibercept, a fusion protein with binding domains from native VEGF receptors, binds VEGF-A, VEGF-B, and placental growth factors 1 and 2 with high affinity. Preclinical ophthalmologic studies demonstrated that aflibercept suppresses choroidal neovascularization in several animal models. The results of phase 1 and 2 trials showed excellent short-term suppression of choroidal neovascularization in patients with exudative agerelated macular degeneration and suggested a longer durability of aflibercept compared with other anti-VEGF drugs. The pivotal phase 3 Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration 1 and 2 trials showed that monthly and bimonthly aflibercept were noninferior to monthly ranibizumab at preventing vision loss (< 15-letter loss) with comparable vision gains and safety. Year 2 treatment involved monthly pro re nata injections with required injections every 3 months and maintained vision gains from the first year, with an average of 4.2 injections of aflibercept and 4.7 injections of ranibizumab. • CONCLUSIONS: Aflibercept promises to deliver excellent visual outcomes for exudative age-related macular degeneration patients while undergoing fewer injections compared with ranibizumab. With a wholesale cost of $1850 per dose, the cost per patient with aflibercept treatment promises to be lower than with ranibizumab. © 2012 by Elsevier Inc. All rights reserved.
Aziz H.A.,Bascom Palmer Eye Institute
Journal of pediatric ophthalmology and strabismus | Year: 2011
A 3-year-old girl with Down syndrome presented with a macular lesion in both eyes. With intraoperative optical coherence tomography confirmation, the patient was diagnosed as having bilateral macular coloboma. These findings were previously reported in two patients with Down syndrome. The documentation of similar findings in three separate patients suggests that macular coloboma may be a rare ophthalmic pathology associated with Down syndrome. Moreover, optical coherence tomography imaging may be a useful adjunct in diagnosing macular coloboma in the pediatric population. Copyright 2011, SLACK Incorporated.
Aziz H.,Bascom Palmer Eye Institute
Ophthalmic surgery, lasers & imaging : the official journal of the International Society for Imaging in the Eye | Year: 2011
The authors report the histopathologic features of a human enucleated eye with an Ex-PRESS shunt (Optonol, Ltd., Neve Ilan, Israel). An 86-year-old man with a blind painful eye underwent enucleation. He had a history of glaucoma with an Ex-PRESS shunt implanted. Histopathologic evaluation of the specimen showed a thin layer of fibrotic tissue surrounding the implant. In this case, the Ex-PRESS shunt was relatively well tolerated in the human eye. Copyright 2011, SLACK Incorporated.
Suk K.K.,Bascom Palmer Eye Institute
Journal of pediatric ophthalmology and strabismus | Year: 2010
Posterior retinopathy of prematurity (ROP) is unusual in its atypical features and its aggressive, rapidly progressive course. It is more difficult to recognize and to treat, with many of these eyes progressing to retinal detachment despite multiple treatments with laser or cryotherapy. The authors present a case of aggressive posterior ROP refractory to multiple laser treatment. This patient was successfully treated with intravitreal bevacizumab, but required repeat treatment 4 months later. The second injection with bevacizumab was followed by progression to retinal detachment requiring surgery. The patient remains stable after surgery. Copyright 2010, SLACK Incorporated.