Dataset Information

Factors associated with the response to fluocinolone acetonide 0.19 mg in diabetic macular oedema evaluated as the area-under-the-curve.

ABSTRACT:

Objectives

The area-under-the-curve (AUC) measures the average drug effect over time. We investigated the impact of baseline clinical and optical coherence tomography (OCT) factors on the response to fluocinolone acetonide (FAc) 0.19 mg implant in patients with diabetic macular oedema (DMO) as the AUC over 36 months.

Methods

Retrospective study of DMO eyes undergoing FAc with follow-up from 12 to 36 months. The AUC of the best-corrected visual acuity (BCVA) and the central macular thickness (CMT) were calculated with the trapezoidal rule. Demographic and clinical data at the time of FAc administration were collected, and associations with BCVA and CMT changes were investigated with linear mixed models.

Results

Eighty-nine eyes of 63 patients were enroled; median follow-up was 26 months. Mean±standard deviation (SD) AUC_BCVA and AUC_CMT after FAc injection were 0.24 ± 0.17 LogMAR/month and 179.6 ± 54.3 μm/month, respectively. Worse baseline BCVA (β = 0.30 LogMAR/month, p < 0.001), higher AUC_CMT after FAc administration (β = 0.08 LogMAR/month, p < 0.001), diagnosis of type 1 diabetes (β = -0.04 LogMAR/month, p = 0.04), and absent ELM/EZ layers (β = 0.06 LogMAR/month, p = 0.01) were associated with worse vision over time (higher AUC_BCVA). Eyes with higher CMT at baseline (β = 9.61 μm/month, p < 0.001) and those with tractional DMO (β = 24.7 μm/month, p = 0.01) had worse anatomic outcomes (higher AUC_CMT). The need for additional treatments after FAc was also associated with higher AUC_CMT (β = 33.9 μm/month, p = 0.001).

Conclusion

Baseline better visual acuity, lower macular thickness, and photoreceptors' layers integrity are associated with better functional response to FAc in DMO. Eyes with severe DMO at the time of implant or tractional oedema have worse anatomic response. These findings might guide clinicians in a more informed decisional algorithm in treating DMO.

SUBMITTER: Cicinelli MV

PROVIDER: S-EPMC9873740 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Factors associated with the response to fluocinolone acetonide 0.19 mg in diabetic macular oedema evaluated as the area-under-the-curve.

Cicinelli Maria Vittoria MV Rabiolo Alessandro A Capone Luigi L Di Biase Carlo C Lattanzio Rosangela R Bandello Francesco F

Eye (London, England) 20220130 2

<h4>Objectives</h4>The area-under-the-curve (AUC) measures the average drug effect over time. We investigated the impact of baseline clinical and optical coherence tomography (OCT) factors on the response to fluocinolone acetonide (FAc) 0.19 mg implant in patients with diabetic macular oedema (DMO) as the AUC over 36 months.<h4>Methods</h4>Retrospective study of DMO eyes undergoing FAc with follow-up from 12 to 36 months. The AUC of the best-corrected visual acuity (BCVA) and the central macular ...[more]

PMID: 35094025

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Project description:BackgroundDiabetic macular oedema (DMO) may lead to visual loss and blindness. Several pharmacological treatments are available on the National Health Service (NHS) to United Kingdom patients affected by this condition, including intravitreal vascular endothelial growth factor inhibitors (anti-VEGFs) and two types of intravitreal steroid implants, releasing dexamethasone or fluocinolone acetonide (FAc). This study aimed to assess the value for money (cost-effectiveness) of the FAc 0.2 μg/day implant (ILUVIEN®) in patients with chronic DMO considered insufficiently responsive to other therapies.MethodsWe developed a Markov model with a 15-year time horizon to estimate the impact of changes in best-corrected visual acuity in DMO patients on costs and quality-adjusted life years. The model considered both eyes, designated as the "study eye", defined at model entry as phakic with an ongoing cataract formation or pseudophakic, and the "fellow eye". The model compared the FAc 0.2 μg/day implant with a 700 μg dexamethasone implant (pseudophakic patients only) or with usual care, defined as a mixture of laser photocoagulation and anti-VEGFs (phakic and pseudophakic patients). Costs were estimated from the perspective of the NHS and Personal Social Services; full NHS prices were used for drugs.ResultsIn patients who were pseudophakic at baseline, at 36 months, the FAc implant provided an additional gain of 4.01 and 3.64 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with usual care and the dexamethasone implant, respectively. Over the 15-year time horizon, this translated into 0.185 additional quality-adjusted life years (QALYs) at an extra cost of £3066 compared with usual care, and 0.126 additional QALYs at an extra cost of £1777 compared with dexamethasone. Thus, incremental cost-effectiveness ratios (ICERs) were £16,609 and £14,070 per QALY gained vs. usual care and dexamethasone, respectively. In patients who were phakic at baseline, the FAc 0.2 μg/day implant provided an additional gain of 2.96 ETDRS letters at 36 months compared with usual care, which, over 15 years, corresponded to 0.11 additional QALYs at an extra cost of £3170, resulting in an ICER of £28,751 per QALY gained.ConclusionThe FAc 0.2 μg/day implant provided good value for money compared with other established treatments, especially in pseudophakic patients.

Dataset Information

Factors associated with the response to fluocinolone acetonide 0.19 mg in diabetic macular oedema evaluated as the area-under-the-curve.

Objectives

Methods

Results

Conclusion

Publications

Factors associated with the response to fluocinolone acetonide 0.19 mg in diabetic macular oedema evaluated as the area-under-the-curve.

Similar Datasets

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