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

Abstract

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^®

Supplementary material

Table S1 Information collected at each retrospective study visit

Acknowledgments

This study was supported by Allergan Inc., Markham, ON, Canada, and is published on behalf of the CHROME Study Group. Writing and editorial assistance was provided by Kakuri Omari, PhD, of Evidence Scientific Solutions, Philadelphia, PA, and was funded by Allergan, Inc., Irvine, CA, USA. All authors met the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship.

Disclosure

W-CL has served as an advisor, consultant, and speaker, and has received travel reimbursement from Allergan Inc. and Novartis, has served as an advisor and received travel reimbursement and institutional grant(s) from Bayer, has served as an advisor and speaker for Alcon, and has served as a speaker for Bausch & Lomb. DAA has served as a consultant to Bausch & Lomb and Bayer, has served as a speaker for Novartis, and received a grant from Allergan Inc. related to the study. PY is a consultant for Bayer and has received honoraria for speaking and developing educational material, and has served as an advisor and speaker for Alcon, Allergan Inc., Bausch & Lomb, and Novartis. JCC has served as an advisor and consultant to Bayer, and received travel reimbursement from Allergan Inc. related to this study. AK has served as an advisor to Allergan Inc. DALM has served as an advisor to Alcon, Allergan Inc., and Bayer. AO has served as a consultant and a speaker, and has received grant(s) from Novartis, and has served as a consultant to Allergan Inc. TR has served as a consultant and speaker, and received honoraria for developing educational material from Alcon, has been a speaker for Allergan Inc., and AMO, and has received honoraria for developing education material from Bausch & Lomb. TGS has served as an advisor to Alcon, Allergan Inc., Bayer, and Novartis. ET has served as an advisor and consultant to Allergan Inc. LW has served as a consultant to Allergan Inc. CS is a statistical consultant to Allergan Inc., and DCB is an employee of Allergan Inc.