Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

Abstract

Purpose To compare dexamethasone (DEX) intravitreal implant effect in nonvitrectomized (non-PPV) vs vitrectomized (PPV) eyes with macular edema (ME) secondary to non-infectious uveitis. Methods Medical records of patients with uveitic ME treated with DEX-intravitreal implant were reviewed. Main outcome measures were changes in central retinal thickness (CRT), best corrected visual acuity (BCVA), intraocular pressure (IOP), vitreous haze and adverse events. Statistical analysis was performed by Longitudinal Linear model using the General Estimating Equation methodology. Results Forty-two eyes of 32 patients were included. Median follow-up time was 18 months (interquartile range (IQR): 12-24). Median CRT showed its maximum decrease at the first month in non-PPV and PPV eyes without statistically significant differences between both groups (P = NS). Median Snellen BCVA, converted to logarithm (LogMAR), showed its maximum improvement at third month in both groups without statistically significant differences between them (P = NS). Median IOP was higher in non-PPV eyes than in PPV eyes from third (P = 0.025) to 12th month (P = 0.013). Vitreous haze score improved in both groups since first month and showed no differences (P = 0.706). Reinjection was performed in 45.2% of eyes at a median time of 5 months IQR: (5-6). Ocular hypertension (47.6%) was the most common adverse event.Conclusions DEX-intravitreal implant for uveitic ME has similar long-term safety profile and good response measured in terms of CRT decrease, BCVA, and vitreous haze improvement in both groups. Non-PPV eyes following DEX-intravitreal implant showed higher IOP increase than PPV eyes, showing the need for close IOP monitoring.

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

“…However, there are several non-randomised trials, with 12-24 months of follow-up, that allow the use of repeat implants. 18,50,51 These studies consistently report that, after around 6 months, patients' outcomes return to those at baseline and that up to three repeat implants are each likely to have a similar treatment effect. Given the limited evidence around repeat implants, this was explored within sensitivity analysis.…”

“…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.…”

“…82 Among studies using a mix of single or multiple implants, in one study systemic corticosteroids or immunosuppressants were reduced in 62% of patients and steroids were discontinued in 36% of patients at 12 months 50 and in another study systemic corticosteroids were reduced or discontinued in 78% of patients and discontinued in 32% of patients at 12 months. 51 …”

“…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.…”

“…Table 3 shows the 6-monthly costs of DEX and ADA. One DEX implant is expected to last around 6 months, based on observational trial data 18,50,51 and clinical advice. It should be noted that patients could receive Chapter 2 Definition of the decision problem T his study assessed the clinical effectiveness and cost-effectiveness of ADA (via subcutaneous injections) and a DEX intravitreal implant for treating inflammation of the posterior segment of the eye presenting as non-infectious uveitis.…”