Real world clinical efficacy and safety profile of Dexamethsone 0.7mg implant (Ozurdex®) in the treatment of diabetic macular oedema in Lanarkshire, Scotland

Session Details

Session Title: Free Paper Session 24: Vascular Diseases & Diabetic Retinopathy VII

Session Date/Time: Sunday 10/09/2017 | 10:00-11:30

Paper Time: 10:24

Venue: Room 117

First Author: : U.Mulla UK

Co Author(s): :    S. Rasool   K. Wong                          

Abstract Details

Purpose:

Dexamethasone 0.7mg implant (Ozurdex®) is approved by the Scottish Medical Consortium (SMC) for use in Scotland in phakic or pseudophakic patients with diabetic macular oedema (DMO) who are unresponsive to or unsuitable for alternative therapies. In MEAD study, dexamethasone 0.7mg (DEX) afforded significant visual acuity gains and reduction in central retinal thickness (CRT) compared to dexamethasone 0.35mg and sham, in patients previously unresponsive to laser, triamcinolone acetate (IVTA) and anti-vascular endothelial growth factor (anti-VEGF). This study aimed to assess the outcomes of DEX in the real world setting.

Setting:

A retrospective observational review of all patients with DMO, treated with DEX from September 2015 to December 2016 in NHS Lanarkshire. 32 eyes (9 bilateral, 14 unilateral) of 23 patients were included in the study. Both phakic and pseudophakic were included as per the approved use of DEX in Scotland.

Methods:

A retrospective case note review of all patients treated with DEX. Primary outcome measures analysed included visual acuity (BCVA in ETDRS letters) and CRT at 6 weeks post injection and every 3 months thereafter up to 6 months. Secondary measures were intraocular pressure (IOP) and development of cataract. Sub-group analysis of treatment naïve and non-treatment naïve patients were also carried out.

Results:

Average age was 62 years. 50% were male and 50% female. Baseline BCVA was 50 ETDRS letters (±19.77), CRT 409µm (±152.47) and IOP 15mmHg (±3.33). 21 patients (65%) were phakic and 11 (35%) were pseudophakic. 9 eyes (28%) were treatment naive. Over the follow up period, 4 patients received more than one DEX. Six patients received rescue anti-VEGF treatment post DEX. At 6 weeks, BCVA improved to a mean of 51.32 ETDRS letters (SEM ±4.46, p=0.5754). At 3 months, BCVA improved to 52.44 ETDRS letters (SEM ±4.60, p= 0.47), and at 6 months to 54.42 ETDRS letters (SEM ±.6.7, p= 0.45). The percentage of patients gaining ≥5 EDTRS letters was 32% at 6 weeks, 27% at 3 months and 59% at 6 months. CRT showed a significant improvement from baseline at 6 weeks, 3 months and 6 months. Reductions were 178.36µm (p=0.0003), 133.67µm (p=0.0033) and 90.25µm (p=0.1587) respectively. An increase in IOP (4.14mmHg, SEM±1.19, p=0.004) at 6 weeks was observed with 3 patients requiring antihypertensive treatment. One patient required IOP lowering treatment after the second DEX injection. One patient (5% of phakic patients) required cataract surgery. However, this patient had mild nucelosclerosis pre-injection.

Conclusions:

This study, on the use of dexamethasone 0.7mg implant in diabetic macular oedema, has demonstrated visual acuity gains over a 6 month period, with a corresponding reduction in central retinal thickness. The treatment naïve group benefited the most with 20.2 ETDRS letter gain at 3 months. Four patients (12.5%) developed raised IOP, which was controlled medically and only one patient required cataract extraction. Dexamethasone 0.7mg implant has been demonstrated as an effective and safe treatment of patients with diabetic macular oedema.

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