Author: Maria Vittoria Cicinelli (Italy)
Co-authors: Maria Vittoria Cicinelli, Alessandro Rabiolo, Luigi Capone, Carlo di Biase, Rosangela Lattanzio, Francesco Bandello
Purpose
To investigate the impact of different baseline demographic, clinical, and optical coherence tomography (OCT) factors on the functional and morphologic response to fluocinolone acetonide (FAc) 0.19 mg implant in patients with diabetic macular edema (DME), evaluated as the area-under-the-curve (AUC).
Setting/Venue
Single-center longitudinal retrospective study
Methods
Pseudophakic eyes with DME who received FAc implant were recruited. The AUC of the best-corrected visual acuity (BCVA expressed as LogMAR) and the central macular thickness (CMT) changes up to 36 months were calculated with the trapezoidal rule. The AUC values were divided by the amount of available follow-up (expressed in months) of each eye, to correct for the heterogeneous follow-up. Demographic and clinical data and OCT features at the time of FAc administration were collected, and their predictive effect on BCVA and CMT was investigated with linear mixed models.
Results
Eighty-one eyes of 63 patients with a minimum 12-month follow-up were enrolled; the median available follow-up was 26 months. All eyes had previously undergone a variable combination of intravitreal treatments with anti-VEGF, dexamethasone (DEX), and macular laser. BCVA improved following FAc implant (p=0.01). The mean AUCBCVA was 0.24±0.17 LogMAR/month. Lower AUCBCVA (better vision during follow-up) was associated with higher baseline BCVA (p<0.001), lower AUCCMT after FAc administration (p<0.001), type 2 diabetes (p=0.04), intact subfoveal ELM/EZ layer (p=0.01). CMT significantly decreased after FAc (p<0.001). The mean AUCCMT was 179.6±54.3 μm/month. Lower AUCCMT (thinner macula during the follow-up) was associated history of anti-VEGF injections administered before FAc (p<0.001). Eyes with higher CMT at baseline (p<0.001) and those with tractional DME (p=0.01) had higher AUCCMT during the follow-up. The need for additional treatments after FAc was also associated with higher AUCCMT for 36 months (p=0.001)
Conlusions
Baseline visual acuity, retinal thickness, and photoreceptors’ integrity were associated with better functional response to FAc implant over time; severe macular edema, undertreated edema, and tractional DME had a worse response to intravitreal sustained-release corticosteroids. In our cohort of eyes with long-standing DME, the duration of the disease did not help to predict the treatment outcomes. These findings might guide clinicians in a more informed decisional algorithm in treating DME.
Financial Disclosure
a. Funding/Support: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. b. Financial disclosures: Maria Vittoria Cicinelli, Alessandro Rabiolo, Luigi Capone, Carlo di Biase: none Rosangela Lattanzio: Allergan Inc (Irvine, California, USA), Novartis (Basel, Switzerland), Bayer Schering-Pharma (Berlin, Germany), Sifi (Aci Sant’Antonio, Italy) Francesco Bandello consultant for Allergan Inc (Irvine, California, USA), Bayer Schering-Pharma (Berlin, Germany), Hoffmann-La-Roche (Basel, Switzerland), Novartis (Basel, Switzerland), Sanofi-Aventis (Paris, France), Thrombogenics (Heverlee, Belgium), Zeiss (Dublin, USA), Boehringer-Ingelheim, Fidia Sooft, Ntc Pharma, Sifi (Aci Sant’Antonio, Italy)
Comments
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