TY - JOUR
T1 - A Collaborative Retrospective Study on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema
T2 - The European DME Registry Study
AU - ARTES Study Group
AU - Rosenblatt, Amir
AU - Udaondo, Patricia
AU - Cunha-Vaz, José
AU - Sivaprasad, Sobha
AU - Bandello, Francesco
AU - Lanzetta, Paolo
AU - Kodjikian, Laurent
AU - Goldstein, Michaella
AU - Habot-Wilner, Zohar
AU - Loewenstein, Anat
N1 - Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
PY - 2020/3
Y1 - 2020/3
N2 - PURPOSE: To evaluate the efficacy, effect profile, and safety of dexamethasone implant on diabetic macular edema (DME) in a real-life setting, further comparing results by DME duration, previous treatment status, and diabetic control.DESIGN: A multicenter, retrospective cohort of 340 DME eyes of 287 patients from 25 clinical sites from 8 countries.METHODS: Data were analyzed in 2 perspectives: per injection, in which all measurements were grouped and baseline was defined as the day of injection, and thus the pharmacodynamics of single injections could be assessed; and injection series, defined as 2 or more injections with 3 to 6 months between injections analyzing the outcome 3 to 6 months after the last injection.MAIN OUTCOME MEASURES: Primary outcome was improvement of 15 or more letters in best-corrected visual acuity (BCVA) from baseline. Secondary outcomes included improvement of 10 letters or more in BCVA, change in central macular thickness (CMT), and time to maximum improvement and safety.RESULTS: Overall, 762 injections were administered to 340 eyes of 287 patients. Injection series analysis included 171 series in 171 eyes of 150 patients, for a total of 444 injections, with a mean follow-up of 1.7±0.8 years. Of the 762 injections analyzed per injection, 22.7% achieved a 15-letter or more improvement, and 37.8% achieved a 10-letter or more improvement. Mean time to peak improvement was 81.9±39.7 days. Mean maximum change in CMT was -174±171 μm. Overall, 7.6% lost 15 or more letters. More eyes with early DME gained 10 or more letters and fewer eyes lost 10 or more letters compared with eyes with late DME (47.4% vs. 33.9% [P = 0.001] and 8.2% vs. 13.5% [P = 0.029], respectively). Patients with controlled diabetes showed greater CMT reduction (P = 0.0002). A higher percentage of treatment-naive patients gained 10 or 15 letter or more in BCVA (P = 0.001 and P = 0.006, respectively). Intraocular pressure elevation of more than 25 mmHg was found following 7.9% of injections; no endophthalmitis was reported.CONCLUSIONS: Dexamethasone implant is an effective and safe treatment for DME. Peak improvement was achieved 3 months after injection and dissipated thereafter. Clinicians and providers may consider shortening treatment intervals.
AB - PURPOSE: To evaluate the efficacy, effect profile, and safety of dexamethasone implant on diabetic macular edema (DME) in a real-life setting, further comparing results by DME duration, previous treatment status, and diabetic control.DESIGN: A multicenter, retrospective cohort of 340 DME eyes of 287 patients from 25 clinical sites from 8 countries.METHODS: Data were analyzed in 2 perspectives: per injection, in which all measurements were grouped and baseline was defined as the day of injection, and thus the pharmacodynamics of single injections could be assessed; and injection series, defined as 2 or more injections with 3 to 6 months between injections analyzing the outcome 3 to 6 months after the last injection.MAIN OUTCOME MEASURES: Primary outcome was improvement of 15 or more letters in best-corrected visual acuity (BCVA) from baseline. Secondary outcomes included improvement of 10 letters or more in BCVA, change in central macular thickness (CMT), and time to maximum improvement and safety.RESULTS: Overall, 762 injections were administered to 340 eyes of 287 patients. Injection series analysis included 171 series in 171 eyes of 150 patients, for a total of 444 injections, with a mean follow-up of 1.7±0.8 years. Of the 762 injections analyzed per injection, 22.7% achieved a 15-letter or more improvement, and 37.8% achieved a 10-letter or more improvement. Mean time to peak improvement was 81.9±39.7 days. Mean maximum change in CMT was -174±171 μm. Overall, 7.6% lost 15 or more letters. More eyes with early DME gained 10 or more letters and fewer eyes lost 10 or more letters compared with eyes with late DME (47.4% vs. 33.9% [P = 0.001] and 8.2% vs. 13.5% [P = 0.029], respectively). Patients with controlled diabetes showed greater CMT reduction (P = 0.0002). A higher percentage of treatment-naive patients gained 10 or 15 letter or more in BCVA (P = 0.001 and P = 0.006, respectively). Intraocular pressure elevation of more than 25 mmHg was found following 7.9% of injections; no endophthalmitis was reported.CONCLUSIONS: Dexamethasone implant is an effective and safe treatment for DME. Peak improvement was achieved 3 months after injection and dissipated thereafter. Clinicians and providers may consider shortening treatment intervals.
KW - Adult
KW - Aged
KW - Dexamethasone/administration & dosage
KW - Diabetic Retinopathy/drug therapy
KW - Drug Implants/therapeutic use
KW - Female
KW - Glucocorticoids/administration & dosage
KW - Humans
KW - Intravitreal Injections
KW - Macular Edema/drug therapy
KW - Male
KW - Middle Aged
KW - Retrospective Studies
KW - Visual Acuity
U2 - 10.1016/j.ophtha.2019.10.005
DO - 10.1016/j.ophtha.2019.10.005
M3 - Article
C2 - 31932090
VL - 127
SP - 377
EP - 393
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 3
ER -