scholarly journals Cumulative Cost of Treatment with ILUVIEN (Fluocinolone Acetonide [FAC]) Versus the Current Standard of Care in the Treatment of Visual Impairment Due to Diabetic Macular Oedema (DMO) in Phakic Eyes Over a 3 Year Period: An Analysis from a UK Healthcare Perspective

2016 ◽  
Vol 19 (7) ◽  
pp. A564 ◽  
Author(s):  
F Quhill
Keyword(s):  
Visual Impairment ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Fluocinolone Acetonide ◽  
Current Standard ◽  
Cost Of Treatment ◽  
Healthcare Perspective ◽  
Cumulative Cost ◽  
Phakic Eyes

scholarly journals The South African macular oedema in diabetics study (the same study): a prospective randomized non-inferiority trial

2020 ◽  
Vol 7 (4) ◽  
pp. 255
Author(s):  
Naseer Ally ◽  
Sarah Ismail ◽  
Bongi P. Sithole ◽  
Mpho Tsimanyane ◽  
Ismail Mayet ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Cost Effective ◽  
Standard Of Care ◽  
Current Standard ◽  
Treat And Extend ◽  
Anti Vegf ◽  
Trial Testing ◽  
Pro Re Nata

<p class="abstract"><strong>Background:</strong> Diabetic retinopathy is the most common cause of visual loss affecting the economically productive age group globally. Diabetic macular oedema (DMO) results from leakage of fluid into the retinal interstitial space. Anti-vascular endothelial growth factor (anti-VEGF) drugs are the first line treatment for DMO. Since monthly injections are required, this treatment regimen can prove very costly. Of the anti-VEGF drugs, bevacizumab is the most cost-effective. The pro re nata (PRN) method is the current standard of care. However, the treat and extend (T and E) regimen can potentially decrease the patient burden on hospitals. Thus far, no randomised clinical trials have been performed using Bevacizumab in a treat and extend versus pro re nata regimen.</p><p class="abstract"><strong>Methods:</strong> A prospective randomised non-inferiority clinical trial testing bevacizumab (1.25 mg) in a treat and extend method versus the pro re nata method is being conducted. Patients will be randomised using a simple computer-based randomised algorithm. The primary outcome is non-inferiority within a five-letter margin for the T and E regimen versus the PRN regimen.</p><p class="abstract"><strong>Conclusions: </strong>This study aims to inform a key area in the literature on the treatment of DMO, i.e. whether a T and E regimen is non-inferior to a PRN regimen in the treatment of DMO with bevacizumab, which is the only anti VEGF available in resource poor settings. It is motivated by the cost involved in the treatment of DMO as well as the treatment burden on both the patient and the health institution at which the patient is receiving treatment.</p><p class="abstract"><strong>Trial registration:</strong> The trial has been registered on the Pan-African clinical trials registry (PACTR202001624880-753).</p>

scholarly journals Surveillance of people with previously successfully treated diabetic macular oedema and proliferative diabetic retinopathy by trained ophthalmic graders: cost analysis from the EMERALD study

2021 ◽  
pp. bjophthalmol-2021-318816
Author(s):  
Mandy Maredza ◽  
Hema Mistry ◽  
Noemi Lois ◽  
Steve Aldington ◽  
Norman Waugh
Keyword(s):  
Diabetic Retinopathy ◽  
Cost Analysis ◽  
Proliferative Diabetic Retinopathy ◽  
Macular Oedema ◽  
Multimodal Imaging ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Current Standard ◽  
Link Type ◽  
The Cost

Background/aimsSurveillance of people with previously successfully treated diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR) adds pressure on ophthalmology services. This study evaluated a new surveillance pathway entailing multimodal imaging reviewed by trained ophthalmic graders and compared it with the current standard care (face-to-face evaluation by an ophthalmologist).MethodsCost analysis of the new ophthalmic grader pathway, compared with the standard of care, from the perspective of the UK National Health Service, based on evidence from the Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy study. Resource use data were prospectively obtained including times to undertake each procedure. Effectiveness was assessed in terms of sensitivity and specificity of referral decisions in the grader pathway. Costs (SDs) were analysed per 100 patients separately for DMO and PDR at 2018/2019 costs.ResultsFor DMO, where sensitivity was very high (97%), the cost difference (savings) for the grader’s pathway would be £1390 per 100 patients. For PDR, the cost would be reduced by £461 for seven-field Early Treatment for Diabetic Retinopathy Study (ETDRS) images and by £1889 for ultrawide field images, per 100 patients. Ultrawide images required less time to be obtained and read than seven-field ETDRS. The real savings would be in ophthalmologist time, which could be then redirected to the evaluation of people at high risk of visual loss.ConclusionsSurveillance of people with previously successfully treated DMO and PDR by trained ophthalmic graders can achieve satisfactory results and release ophthalmologist time.Trial registration numbersNCT03490318, ISRCTN10856638.

scholarly journals Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

Eye ◽  
2021 ◽  
Author(s):  
Clare Bailey ◽  
◽  
Usha Chakravarthy ◽  
Andrew Lotery ◽  
Geeta Menon ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Clinical Effectiveness ◽  
Fluocinolone Acetonide ◽  
Prior History ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Laser Trabeculoplasty ◽  
Retrospective Audit ◽  
History Of

Abstract Background This study aimed to assess the long-term effectiveness of the 0.2 μg/day fluocinolone acetonide (FAc) implant over ≥3 years for patients with diabetic macular oedema. Methods A retrospective audit of pseudo-anonymised data from patients with chronic diabetic macular oedema (cDMO) and treated with the FAc implant across 14 UK clinical sites. Safety and clinical effectiveness were measured. Results Two-hundred and fifty-six eyes had ≥3 years of follow-up (mean 4.28 years), during which a mean of 1.14 FAc implants were used per eye. Mean best-recorded visual acuity (BRVA) increased from 52.6 to 56.7 letters at month 3 and remained stable thereafter; this trend was also seen in pseudophakic eyes. The proportion of patients attaining a BRVA ≥6/12 increased from 17% at baseline to 27% 1 month after FAc implant and remained stable above 30% from month 12 onwards. Eyes with no prior history of intraocular pressure (IOP)-related events required significantly less treatment-emergent IOP-lowering medication than those with a prior history of IOP events (17.9% vs. 50.0% of eyes; p < 0.001). The incidence of an IOP increase of ≥10 mmHg, use of IOP-lowering medication, laser trabeculoplasty and IOP-lowering surgery was 28.9%, 29.7%, 0.8% and 2.7%, respectively, for the whole cohort. There were significant reductions in mean central foveal thickness and macular volume (p < 0.001). Conclusions The FAc implant was well tolerated, with predictable and manageable IOP-related events while delivering a continuous microdose of corticosteroid to eyes with cDMO, providing prolonged vision preservation and a reduced number of treatments.

Visual Function and Structure Outcomes in a Patient with Diabetic Macular Oedema Insufficiently Responsive to Available Therapies – Treatment with Fluocinolone Acetonide Implant

2014 ◽  
Vol 08 (02) ◽  
pp. 137
Author(s):  
Érica ABC Guerreiro Paulo ◽  
Claus Eckardt ◽  
◽  
Keyword(s):  
Visual Function ◽  
Macular Oedema ◽  
Therapeutic Option ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Eye Drops ◽  
Short Term ◽  
Patient Reported ◽  
Before And After ◽  
Insufficient Response

Importance:Early experience with intraocular, non-biodegradable fluocinolone acetonide (FAc) (0.2 μg/day) implant (ILUVIEN®), comparing visual function before and after treatment in an insufficiently responsive diabetic macular oedema (DMO) patient.Observations:This 62-yearold male patient with type 2 diabetes mellitus was first treated for DMO in 2004, when best corrected visual acuity (BCVA) was 0.8 for his right eye. He did not visit an ophthalmologist again until 2011 when BCVA had declined to 0.2. Three separate, monthly intravitreal (IV) ranibizumab injections and additional laser photocoagulation resulted in no improvement. Subsequently, 0.7 mg IV dexamethasone was administered, giving short-term DMO improvement. However, six further IV ranibizumab injections produced no effect and a combined injection of IV ranibizumab with 0.7 mg IV dexamethasone provided only short-term improvements. Following phacoemulsification, a 0.2 μg/day FAc implant was administered. Optical coherence tomography (OCT) indicated complete DMO regression after 3 weeks, sustained 6 months post-implant. BCVA improved to 0.25 and the patient reported greater vision-related quality of life. Intraocular pressure increased gradually but resolved with daily timolol/dorzolamide and tafluoprost eye drops.Conclusions and relevance:In a DMO patient showing insufficient response to IV ranibizumab and dexamethasone injections, FAc implant provided an effective therapeutic option with manageable side effects.

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