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Diabetic Macular Oedema Case Study
Visual Function and Structure Outcomes in a Patient with Diabetic
Macular Oedema Insufficiently Responsive to Available Therapies –
Treatment with Fluocinolone Acetonide Implant
Érica ABC Guerreiro Paulo 1 and Claus Eckardt 2
1. Ophthalmology Resident, Department of Ophthalmology, Klinikum Frankfurt Höchst, Frankfurt am Main, Germany;
2. Chief, Department of Ophthalmology, Klinikum Frankfurt Höchst, Frankfurt am Main, Germany
Abstract 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-year-
old 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.
Keywords Diabetic macular oedema, fluocinolone acetonide
Disclosure: Érica ABC Guerreiro Paulo and Claus Eckardt have no conflicts of interest to declare.
Acknowledgements: Medical writing and editorial assistance was provided by QXV Communications, Macclesfield, UK and was funded by Alimera Sciences.
Compliance with Ethics Guidelines: All procedures were followed in accordance with the responsible committee on human experimentation and with the Helsinki
Declaration of 1975 and subsequent revisions. Informed consent was received from the patient involved in this case study.
Received: 5 September 2014 Accepted: 5 November 2014 Citation: European Ophthalmic Review, 2014;8(2):137–9
Correspondence: Érica ABC Guerreiro Paulo, Sandhöfer Allee 10, 60528 Frankfurt am Main, Germany. E: firstname.lastname@example.org
Support: The publication of this article was funded by Alimera Sciences Ltd.
Diabetic retinopathy (DR) is the most common cause of moderate-to-
severe visual impairment among working class adults. 1 Diabetic macular
oedema (DMO), a common manifestation of DR, causes central vision loss, 2
and is a consequence of vascular inner blood–retinal barrier breakdown. 3
Global prevalence of DR among diabetic individuals is approximately
35 %, with DMO present in 6.8 %. 4 DMO is difficult to manage due to its
The Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study
compared 0.2 μg/day FAc with sham injections in patients with DMO,
a baseline best corrected VA (BCVA) in Early Treatment Diabetic
Retinopathy Study (ETDRS) letter score between 19–68 (20/50–20/400),
central foveal thickness (CFT) ≥250 µm, and ≥1 prior focal laser
treatment. 11 Patients receiving non-protocol treatments were included.
chronicity. Historically, the standard of care was laser therapy; however, a
large number of patients continued to lose vision, 1,5 with significant vision
recovery in only 15 % of treated patients. 11 In particular, patients presenting
with diffuse DMO, where causal vascular abnormalities are not restricted
to discrete foci, are likely to be refractory to laser therapy. 6 Given the
proportion of patients with DMO refractory to laser therapy, new therapies
providing sustained benefit are needed. 7
Patients were eligible for rescue laser after 6 weeks or retreatment with
assigned therapy after 1 year.
Alternative DMO treatments are evolving rapidly, with a number
demonstrating promise in preventing visual acuity (VA) deterioration and
improving vision. 1,2 One such treatment is fluocinolone acetonide (FAc)
(0.2 μg/day, ILUVIEN ® ), 8 a non-biodegradable, intravitreal (IV) corticosteroid
implant, 9 which releases daily sustained, low-dose FAc for 3 years. 10
© To u ch MEd ica l MEdia 201 4
Three-year treatment with 0.2 μg/day FAc improved BCVA in 34.0 % of
chronic (≥3 years median duration) DMO patients compared with 13.4 %
sham-treated patients, with mean changes in BCVA score of 7.6 and 1.8
letters, respectively. 7 CFT rapidly and substantially decreased from baseline
in both FAc- and sham-treated chronic DMO patients. 7 Although at 36
months FAc implant patients needed cataract surgery more frequently
than those patients who received sham injection, their post-surgery
visual benefit was similar to subjects pseudophakic at baseline. Surgery
to manage elevated intraocular pressure (IOP) was also more frequent for
FAc-treated patients compared with sham (4.8 % versus 0.5 %). 7