Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study

Abstract

BackgroundThe purpose of this study was to evaluate the real-world use, efficacy, and safety of one or more dexamethasone intravitreal implant(s) 0.7 mg (DEX implant) in patients with macular edema (ME).MethodsThis was a retrospective cohort study of patients with ME secondary to retinal disease treated at ten Canadian retina practices, including one uveitis center. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP), glaucoma and cataract surgery, and safety data were collected from the medical charts of patients with ≥3 months of follow-up after the initial DEX implant.ResultsOne hundred and one patient charts yielded data on 120 study eyes, including diagnoses of diabetic ME (DME) (n=34), retinal vein occlusion (RVO, n=30; branch in 19 and central in 11), and uveitis (n=23). Patients had a mean age of 60.9 years, and 73.3% of the study eyes had ME for a duration of ≥12 months prior to DEX implant injection(s). Baseline mean (± standard error) BCVA was 0.63±0.03 logMAR (20/86 Snellen equivalents) and mean CRT was 474.4±18.2 μm. The mean number of DEX implant injections was 1.7±0.1 in all study eyes; 44.2% of eyes had repeat DEX implant injections (reinjection interval 2.3–4.9 months). The greatest mean peak changes in BCVA lines of vision occurred in study eyes with uveitis (3.3±0.6, P<0.0001), followed by RVO (1.3±0.5, P<0.01) and DME (0.7±0.5, P>0.05). Significant decreases in CRT were observed: −255.6±43.6 μm for uveitis, −190.9±23.5 μm for DME, and −160.7±39.6 μm for RVO (P<0.0001 for all cohorts). IOP increases of ≥10 mmHg occurred in 20.6%, 24.1%, and 22.7% of DME, RVO, and uveitis study eyes, respectively. IOP-lowering medication was initiated in 29.4%, 16.7%, and 8.7% of DME, RVO, and uveitis study eyes, respectively. Glaucoma surgery was performed in 1.7% of all study eyes and cataract surgery in 29.8% of all phakic study eyes receiving DEX implant(s).ConclusionDEX implant(s) alone or combined with other treatments and/or procedures resulted in functional and anatomic improvements in long-standing ME associated with retinal disease.

A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

“…18 Another study reported that the improvements in BCVA and central retinal thickness at 1 month were similar (not significantly different) following the first and second implants. 84 In a study of uveitis patients the median time from first to second implant was 10 months 50 whereas in four studies of uveitic macular oedema the mean/median time from first to second implant was 4.7, 81 5.0, 51 7.1 83 and 10 86 months. The mean time from second to third implant was 3.4 months in one study of uveitic macular oedema.…”

“…18,50,51,[79][80][81][82][83][84][85][86] This is based on data from the company submission for DEX; 43 the original study publications have not been examined because of time constraints. These data are included here as they provide some data on repeat implants, implants in both eyes and corticosteroid reduction, which were not assessed in the HURON trial.…”

“…The mean time from second to third implant was 3.4 months in one study of uveitic macular oedema. 81 Implants in both eyes were assessed in one study, with 3 out of 11 patients (27%) receiving implants in both eyes having a response (reduced central retinal thickness and improved BCVA) in the second eye. 18 In terms of reduction in other therapies following a single implant, one study reported that 21 out of 27 patients (78%) reduced or stopped systemic or local treatment, 18 whereas in another study 3 out of 12 patients (25%) reduced their corticosteroid dose 79 and in another study systemic corticosteroids were reduced or discontinued in 14 out of 32 patients (44%) and discontinued in 8 out of 32 patients (25%) at 6 months.…”

Effectiveness and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema: A Real-World Experience

“…Moreover, these implants have the potential to reduce the costs and overall treatment burden associated with other therapies [14]. Although an intravitreal dexamethasone implant (Ozurdex at a dose of 0.7 mg; Allergan Inc., Irvine, CA, USA) has been available in Brazil since 2012, unlike other countries [15-20] no clinical studies have been reported thus far assessing the use of this product specifically in the treatment of DME. We aimed to assess the real-world use of this product in order to further characterize its effectiveness and safety among patients with DME treated in Latin America.…”

Update in the Management of Macular Edema Following Retinal Vein Occlusions

“…Aflibercept (Eylea®; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA) was approved for CRVO in September 2012 and for BRVO in 2014. [13,14]…”