6 results on '"David A Eichenbaum"'
Search Results
2. Biosimilars in the Treatment of Retinal Disease in the United States
- Author
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Priya S. Vakharia, David A. Eichenbaum, and Caroline R. Baumal
- Abstract
Biosimilars have recently emerged into the vitreoretinal pharmaceutical market. This review defines biosimilars, discusses the approval process, and reviews the benefits, risks, and controversies regarding biosimilars. This review also discusses ranibizumab biosimilars that have recently received United States Food and Drug Administration approval in the United States and discusses anti-vascular endothelial growth factor biosimilars that are in development. [ Ophthalmic Surg Lasers Imaging Retina 2023;54:xx–xx.]
- Published
- 2023
- Full Text
- View/download PDF
3. The 0.19-mg Fluocinolone Acetonide Implant for the Treatment of Diabetic Macular Edema: An Expert Consensus
- Author
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Anton M. Kolomeyer, David A. Eichenbaum, Daniel F. Kiernan, Ivan J. Suñer, and Seenu M. Hariprasad
- Abstract
Background and Objective: To better understand the level of agreement among retina specialists on the role of inflammation in diabetic retinopathy (DR) and diabetic macular edema (DME), and the use of 0.19-mg fluocinolone acetonide (FAc) implant in DME treatment, a consensus survey was drafted and disseminated to retina specialists across the United States. Materials and Methods: Using the modified Delphi method, a list of 12 consensus statements were generated by the coauthors based on short-answer responses to an initial survey. In total, 56 retina specialists completed the entire consensus survey. Except for two multiple-choice questions, there were 10 consensus statements that used a modified Likert scale to indicate their level of agreement to the statement: Agree = 3, Mostly Agree = 2, Mostly Disagree = 1, Disagree = 0. Percentage agreement and 95% confidence intervals (CIs) were calculated, and a consensus threshold was set at > 80% agreement for each statement. Results: Seven of 10 consensus statements using the modified Likert scale reached consensus, including those on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. The remaining three statements displayed high agreement with average scores > 80%, but the 95% CIs were below threshold. These included the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. Two multiple-choice questions focused on clinical situations in which corticosteroids would be used as baseline therapy for DME (pseudophakic eye [73%], recent stroke/myocardial infarction [66%], and pregnancy/breastfeeding [66%]) and which delivery route satisfies the steroid challenge for the FAc implant (intravitreal [100%], sub-tenon/periocular [73%], and topical [57%]). Conclusions: Physicians highly agreed on the role of inflammation in pathophysiology of DR/DME, injection burden and patient adherence, and efficacy and safety of the FAc implant. However, full consensus was not found on the impact of the FAc implant on DR progression, FAc as baseline therapy for DME, and the effectiveness of the steroid challenge to mitigate intraocular pressure risk after FAc use. [ Ophthalmic Surg Lasers Imaging Retina. 2023;54(3):166–173.]
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- 2023
- Full Text
- View/download PDF
4. Monthly Versus Treat-and-Extend Ranibizumab for Diabetic Macular Edema: A Prospective, Randomized Trial
- Author
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Scott M Pollack, David A Eichenbaum, Emily Duerr, and Hershel R Patel
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Visual acuity ,genetic structures ,Fundus Oculi ,Visual Acuity ,Angiogenesis Inhibitors ,Pilot Projects ,Treat and extend ,Drug Administration Schedule ,Macular Edema ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Ranibizumab ,Ophthalmology ,medicine ,Humans ,Macula Lutea ,Prospective Studies ,Dosing ,Fluorescein Angiography ,Prospective cohort study ,Aged ,Aged, 80 and over ,Diabetic Retinopathy ,Dose-Response Relationship, Drug ,medicine.diagnostic_test ,business.industry ,Middle Aged ,Fluorescein angiography ,Confidence interval ,Treatment Outcome ,Intravitreal Injections ,030221 ophthalmology & optometry ,Female ,sense organs ,medicine.symptom ,business ,Tomography, Optical Coherence ,030217 neurology & neurosurgery ,Follow-Up Studies ,medicine.drug - Abstract
BACKGROUND AND OBJECTIVE: Compare fixed monthly dosing of ranibizumab to treat-and-extend (T&E) ranibizumab during a period of 24 months for diabetic macular edema (DME) treatment. PATIENTS AND METHODS: Single-center, randomized, prospective pilot study that included 20 eyes of 20 subjects. Patients' best-corrected visual acuity (BCVA) was less than or equal to 20/40 and central foveal thickness on spectral-domain optical coherence tomography was greater than 325 µm. Intravitreal ranibizumab was dosed monthly or by protocol-specified treat-and-extend. Primary outcome was mean change in mean BCVA. Institutional review board approval was obtained. RESULTS: At month 24 (M24), there was a mean 8.3-letter gain in the monthly treatment group and an 8.5-letter gain in the T&E group ( P = .082; 90% confidence interval). The average change from baseline BCVA was not statistically significantly different at any timepoint. At M24, the median number of injections in the monthly and T&E groups were 22.5 and 18.5, respectively ( P = .287). CONCLUSIONS: Visual acuity with monthly dosing appears equivalent to T&E dosing during the course of 24 months. There was a trend toward a lower injection burden in the T&E arm. [ Ophthalmic Surg Lasers Imaging Retina. 2018;49:e191–e197.]
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- 2018
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5. Geographic atrophy: clinical impact and emerging treatments
- Author
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Seenu M. Hariprasad, David A Eichenbaum, and Hershel R Patel
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medicine.medical_specialty ,Cell Survival ,business.industry ,Anti-Inflammatory Agents ,Retinal Pigment Epithelium ,Blindness ,Geographic atrophy ,Oxidative Stress ,Geographic Atrophy ,Internal medicine ,Animals ,Humans ,Medicine ,business ,Photoreceptor Cells, Vertebrate ,Stem Cell Transplantation - Published
- 2015
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6. Topical Lidocaine Gel With and Without Subconjunctival Lidocaine Injection for Intravitreal Injection: A Within-Patient Study
- Author
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Scott E. Pautler, Karina Billiris-Findlay, David A Eichenbaum, and Steven M. Cohen
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Male ,Lidocaine ,Administration, Topical ,Angiogenesis Inhibitors ,Topical anesthesia ,Retinal Diseases ,Humans ,Medicine ,Single-Blind Method ,Prospective Studies ,Anesthetics, Local ,Aged ,Aged, 80 and over ,business.industry ,Patient Preference ,Patient preference ,Patient study ,Topical lidocaine ,Anesthesia ,Intravitreal Injections ,Female ,Injections, Intraocular ,business ,Conjunctiva ,Gels ,Anesthesia, Local ,medicine.drug - Abstract
BACKGROUND AND OBJECTIVE: To determine whether patients prefer topical anesthesia or subconjunctival anesthesia for intravitreal injection. PATIENTS AND METHODS: Consecutive patients receiving bilateral simultaneous injections of anti-vascular endothelial growth factor agents were asked to participate in this within-patient, prospective, single-blinded, randomized, factorial study. Fifty-seven patients completed the study. Both eyes were treated with topical anesthesia. One eye was also injected with subconjunctival lidocaine. Anesthesia for the next treatment visit was based on patient preference at the conclusion of the study visit and at a 4-hour and 24-hour follow-up telephone call. Patients were allowed to change their anesthesia preference during the next three visits. The final endpoint for the study was anesthesia preference for ongoing intravitreal injections. RESULTS: Fifty patients (88%) preferred subconjunctival anesthesia and seven patients (12%) preferred topical anesthesia for ongoing treatments. ( P = .0003) CONCLUSION: Given the choice, most patients prefer subconjunctival anesthesia to topical anesthesia for intravitreal injections. [ Ophthalmic Surg Lasers Imaging Retina . 2014;45:306–310.]
- Published
- 2014
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