Sara Vaz-Pereira1,2, João Paulo Castro-de-Sousa3,4,5, David Martins6, Joaquim Prates Canelas7,8, Pedro Reis9, António Sampaio10, Helena Urbano11, Paulo Kaku12, João Nascimento13, Carlos Marques-Neves7,8,14. 1. Department of Ophthalmology, Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon, Portugal, saravazpereira@gmail.com. 2. Department of Ophthalmology, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal, saravazpereira@gmail.com. 3. Department of Ophthalmology, Centro Hospitalar de Leiria, Leiria, Portugal. 4. CICS-UBI, Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal. 5. Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal. 6. Department of Ophthalmology, Centro Hospitalar de Setúbal, Setúbal, Portugal. 7. Department of Ophthalmology, Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon, Portugal. 8. Department of Ophthalmology, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal. 9. Department of Ophthalmology, Hospital das Forças Armadas, Lisbon, Portugal. 10. Instituto de Microcirurgia Ocular, Lisbon, Portugal. 11. Department of Ophthalmology, Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz, Lisbon, Portugal. 12. Department of Ophthalmology, Hospital da Cruz Vermelha Portuguesa, Lisbon, Portugal. 13. Instituto de Retina de Lisboa, Lisbon, Portugal. 14. ALM Oftalmolaser, Lisbon, Portugal.
Abstract
BACKGROUND: First-line treatment for diabetic macular edema (DME) is usually with antivascular endothelial growth factor agents, followed by intravitreal corticosteroids as a second-line treatment option. Long-term corticosteroids may offer quality of life and effectiveness benefits over short-term implants. OBJECTIVES: To evaluate outcomes of patients with persistent or recurrent DME who switched from a short-term (dexamethasone) to a long-term (fluocinolone acetonide, FAc) corticosteroid intravitreal implant in a real-world setting. METHODS: This is a retrospective study in 9 Portuguese centers. An FAc intravitreal implant was administered according to product labeling. Effectiveness outcomes were mean change in visual acuity (VA; ETDRS letters), central retinal thickness (CRT; µm), and macular volume (MV; mm3). The safety outcome was mean change in intraocular pressure (IOP; mm Hg). All were analyzed at months 1 and 3, and then quarterly until month 24 after implantation. RESULTS: Forty-four eyes from 36 patients were analyzed. Mean duration of DME was 3.3 ± 1.9 years, and mean follow-up was 8 months. From baseline following FAc implantation, VA increased significantly at months 1 and 6 (mean +6.82 and +13.02 letters, respectively; p = 0.005), and last observation carried forward (LOCF; mean +8.3 letters; p = 0.002). CRT improved significantly at months 1 and 6 (mean -71.81 and -170.77 µm, respectively; p = 0.001), and LOCF (mean -121.46 µm; p = 0.001). MV was consistently, but not significantly, decreased from baseline to LOCF (mean -0.69 mm3; p = 0.062). The mean change in IOP was -0.25 and +0.88 mm Hg at months 1 and 6, respectively (p = 0.268), and +1.86 mm Hg at LOCF (p = 0.036). Increases were controlled with topical medication in most cases. CONCLUSIONS: The FAc intravitreal implant is effective in patients previously treated with short-term corticosteroid implants. Thus, after a suboptimal response to antiangiogenics or a short-term corticosteroid, a single FAc implant may be considered an effective and tolerable treatment that can improve long-term outcomes for patients with sight-threatening DME.
BACKGROUND: First-line treatment for diabetic macular edema (DME) is usually with antivascular endothelial growth factor agents, followed by intravitreal corticosteroids as a second-line treatment option. Long-term corticosteroids may offer quality of life and effectiveness benefits over short-term implants. OBJECTIVES: To evaluate outcomes of patients with persistent or recurrent DME who switched from a short-term (dexamethasone) to a long-term (fluocinolone acetonide, FAc) corticosteroid intravitreal implant in a real-world setting. METHODS: This is a retrospective study in 9 Portuguese centers. An FAc intravitreal implant was administered according to product labeling. Effectiveness outcomes were mean change in visual acuity (VA; ETDRS letters), central retinal thickness (CRT; µm), and macular volume (MV; mm3). The safety outcome was mean change in intraocular pressure (IOP; mm Hg). All were analyzed at months 1 and 3, and then quarterly until month 24 after implantation. RESULTS: Forty-four eyes from 36 patients were analyzed. Mean duration of DME was 3.3 ± 1.9 years, and mean follow-up was 8 months. From baseline following FAc implantation, VA increased significantly at months 1 and 6 (mean +6.82 and +13.02 letters, respectively; p = 0.005), and last observation carried forward (LOCF; mean +8.3 letters; p = 0.002). CRT improved significantly at months 1 and 6 (mean -71.81 and -170.77 µm, respectively; p = 0.001), and LOCF (mean -121.46 µm; p = 0.001). MV was consistently, but not significantly, decreased from baseline to LOCF (mean -0.69 mm3; p = 0.062). The mean change in IOP was -0.25 and +0.88 mm Hg at months 1 and 6, respectively (p = 0.268), and +1.86 mm Hg at LOCF (p = 0.036). Increases were controlled with topical medication in most cases. CONCLUSIONS: The FAc intravitreal implant is effective in patients previously treated with short-term corticosteroid implants. Thus, after a suboptimal response to antiangiogenics or a short-term corticosteroid, a single FAc implant may be considered an effective and tolerable treatment that can improve long-term outcomes for patients with sight-threatening DME.
Authors: Mark C Gillies; Florian K P Sutter; Judy M Simpson; Jorgen Larsson; Haipha Ali; Meidong Zhu Journal: Ophthalmology Date: 2006-07-07 Impact factor: 12.079
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Authors: Michael E Jansen; Chelsey J Krambeer; Daniel S Kermany; Jana N Waters; Wayne Tie; Sepehr Bahadorani; Julia Singer; Jordan M Comstock; Kendall W Wannamaker; Michael A Singer Journal: Ophthalmic Surg Lasers Imaging Retina Date: 2018-03-01 Impact factor: 1.300