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

Abstract

Wai-Ching Lam,1 David A Albiani,2 Pradeepa Yoganathan,3 John Chanchiang Chen,4 Amin Kherani,5 David AL Maberley,6 Alejandro Oliver,7 Theodore Rabinovitch,3 Thomas G Sheidow,8 Eric Tourville,9 Leah A Wittenberg,10 Chris Sigouin,11 Darryl C Baptiste12 1Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, 2West Coast Retinal Consultants, Vancouver, BC, 3North Toronto Eye Care, North York, ON, 4Department of Ophthalmology, McGill University, Montreal, QC, 5Southern Alberta Eye Center, Calgary, AB, 6Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, 7Timmins and District Hospital, Timmins, ON, 8Ivey Eye Institute, London, ON, 9Center Oculaire de Quebec, Quebec City, QC, 10Retina Surgical Associates, New Westminster, BC, 11Clinwest Research Inc, Burlington, ON, 12Allergan Inc., Markham, ON, Canada Background: The 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).Methods: This 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.Results: One 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).Conclusion: DEX 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. Keywords: diabetic macular edema, posterior segment inflammatory disease, retinal vein occlusion, registry, sustained-release dexamethasone implant, Ozurdex®