Intravitreal fluocinolone acetonide implant for the treatment of persistent post-surgical cystoid macular edema in vitrectomized eyes

Cystoid macular edema (CME) is the most common cause of decreased visual acuity after both vitrectomy and cataract surgery. Various strategies have been used for its treatment, such as intravitreal corticosteroids. The intravitreal fluocinolone acetonide implant (Iluvien®) is approved for the treatment of persisting diabetic macular edema and for the prevention of recurrence of non-infectious uveitis affecting the posterior segment. There are very few reports about its off-label use for post-surgical CME. We present four clinical cases of post-surgical CME (three following vitrectomy and one following cataract surgery in a vitrectomized eye 2 years ago). All of them had been previously treated with an average of four injections of intravitreal dexamethasone implant (Ozurdex®), with repeated recurrence of CME. After treatment with Iluvien, three cases showed improvement of both visual acuity and macular anatomy, with resolution of the macular edema. One patient required additional treatment with Ozurdex during follow-up, further improving CME. Two of the cases required topical pressure lowering treatment, and none required filtering surgery. Iluvien could be an effective therapeutic option for persistent non-diabetic macular edema after vitrectomy or cataract surgery refractory to other intravitreal therapies, with the benefit of being able to provide longer recurrence-free periods.

Intravitreal 0.19 mg Fluocinolone Acetonide Implant in Non-Infectious Uveitis

The efficacy of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) in the treatment of non-infectious uveitic macular edema (UME) was assessed on twenty-six patients (34 eyes) with non-infectious UME between 2013 and 2020, in a mean follow-up of 18 ± 19.3 (mean ± SD) months. Macular edema was resolved in 24 (70.6%) cases. Five of these eyes had a relapse after 23.2 ± 14 months. Three FAc reinjections were performed and a drying of the macula was observed. After FAc implantation, 24 eyes (70.6%) were completely dry; central retinal thickness (CRT) decreased in 6 eyes (17.6%), but residual intraretinal fluid was still evident. In 20 eyes (58.5%), visual acuity (VA) improved (from +1 to +5 lines) and remained stable in 9 eyes (26.5%). Thirty eyes (88.2%) were pseudophakic at baseline and four were phakic. Three of these eyes had a cataract prior to therapy and the other developed a cataract 2.5 years after the FAc implant was administered. There was an overall increase in intraocular pressure (IOP; +4.4 ± 3.7 mmHg) and eye drops were required in three eyes. The FAc implant led to long-term improvements in mean CRT and VA, and that the side-effect profile was manageable in a clinical setting in patients with non-infectious UME.

Intraocular Pressure Changes Are Predictive of Ocular Hypertension Onset After Fluocinolone Acetonide Implant: Significant Cutoffs and the Role of Previous DEX Implant

Background: Fluocinolone acetonide (FAc) implant represents a long-term strategy for the management of diabetic macular edema (DME). Because of the 3-year duration, the careful monitoring of the intraocular pressure (IOP) is necessary. The main aim of the study was to provide quantitative IOP cutoffs associated with the onset of IOP increases.Methods: The study was retrospectively conducted with 2-year of follow-up. We separately considered eyes with good IOP control (Group 1), eyes requiring IOP-lowering medications (Group 2) and eyes undergoing IOP-lowering surgery (Group 3). The statistical analysis assessed Delta% IOP changes over the 2-year follow-up. ROC analysis was performed to detect significant cutoffs associated with Group 2 and Group 3. IOP changes occurring after a previously administered dexamethasone (DEX) implant were also evaluated.Results: We included 48 eyes (48 patients), stratified as follows: Group 1 (25/48; 52%), Group 2 (19/48; 40%) and Group 3 (4/48; 8%). ROC analysis performed on IOP values detected 2-months later DEX implant showed a mean Delta IOP increase>24% significantly associated with IOP-lowering medications after FAc implant, whereas a mean Delta IOP increase>35% was significantly associated with IOP-lowering surgery after FAc implant. With respect to IOP changes occurred after FAc implant, our ROC analysis showed a mean Delta IOP increase>8% significantly associated with IOP-lowering medications, whereas a mean Delta IOP increase>15% was significantly associated with IOP-lowering surgery. DEX-related IOP changes showed 52% sensitivity and 100% specificity of FAc-related IOP increases.Conclusions: IOP changes provides clinically relevant cutoffs associated with the onset of FAc-related IOP increases.

The impact of vitrectomy on outcomes achieved with 0.19 mg fluocinolone acetonide implant in patients with diabetic macular edema

Background: There is a lack of consensus on the use of intravitreal corticosteroid therapies in patients with diabetic macular edema (DME) and prior vitrectomized eyes in clinical practice. Methods: Retro-IDEAL was a 3-year retrospective, multicenter study in patients with chronic DME (i.e. DME that persists or recurs despite treatment) treated with ILUVIEN® (0.2 µg daily fluocinolone acetonide intravitreal implant), who had suboptimal outcomes with first-line vascular endothelial growth-factor inhibitors and other DME therapies. Results: A total of 81 eyes (63 patients) were included of which 39 eyes had undergone prior vitrectomy (PV group) while 42 eyes had not undergone prior vitrectomy (NPV). Baseline characteristics were balanced; however, more patients had proliferative diabetic retinopathy in the PV group vs. the NPV group (21.62% vs 9.38%, respectively). Over 36 months, mean visual acuity (VA) increased in both groups with a tendency for more ETDRS letters being gained in the NPV group (+5.33) vs. the PV group (+2.42). By month 36, central retinal thickness was reduced to ⩽300 µm in two-thirds of the eyes in both groups and the mean change from baseline in intraocular pressure was similar in both groups (+0.50 mmHg −0.75 mmHg; NPV and PV group). Conclusions: These long-term data suggest that the 0.2 μg/day FAc implant is effective in both vitrectomized and non-vitrectomized patients, with a manageable safety profile, and improved VA and reduced supplemental therapies for patients with a suboptimal response to first-line DME therapies. Clinicians may consider utilizing the FAc implant earlier in the DME disease process.

Optical Coherence Tomography Biomarkers - Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19 mg Fluocinolone Acetonide Implant

Background: The 0.19 mg fluocinolone acetonide (FAc) implant (ILUVIEN®; Alimera Sciences Ltd, Hampshire, UK) was approved for the treatment of vision impairment associated with chronic and refractory diabetic macular edema (DME). Objectives: To quantitatively assess functional and structural features in non-vitrectomized and vitrectomized DME patients after being treated with a FAc implant Methods: Retrospective review of patients with DME receiving single intravitreal injection of the FAc implant. The study was designed to analyze the presence of quantitative structural OCT biomarkers at baseline and 12 months after FAc therapy according to vitreous status. Results: A total of 41 eyes from 30 patients were included in this study. At 12 months post-injection, vitrectomized patients had a lower central foveal thickness (CFT, p=0.017) and fewer hyperreflective dots (HRD, p=0.028) compared with non-vitrectomized. Thirty (73%) patients presented a significant functional improvement with 17 (42%) increasing at least 15 ETDRS letters. Overall, 22 (54%) eyes had a complete resolution of DME at 12 months visit. Patients who needed additional therapy had a higher prevalence of subretinal fluid (SRF, 42% vs 3% p=0.005) at baseline. Conclusions: This study supports the effectiveness of the FAc implant and reports significant changes at 12 months post-FAc injection.

Switching to intravitreal fluocinolone acetonide implant for refractory diabetic macular edema: 12- and 24-month results

Purpose: To report visual and anatomical outcomes of chronic/refractory diabetic macular edema (DME) treated with intravitreal fluocinolone acetonide implant. Setting: Retrospective, one arm, multicentric study. Method: Between 2013 and 2018, 27 consecutive eyes of 25 patients with chronic/refractory DME were treated with a fluocinolone acetonide intravitreal implant. Best registered visual acuity (BRVA), central retinal thickness (CRT), and Goldmann tonometry intraocular pressure (IOP) were assessed at 12 and 24 months. The need for IOP lowering treatment as well as top-up therapy during the follow-up were also assessed. Results: The duration of DME prior to treatment in our study was 54 ± 24 months. The baseline mean BRVA of 0.7 ± 0.34 logMAR improved to 0.5 ± 0.3 ( p = 0.01) at 12 months and 0.46 ± 0.3 ( p = 0.04) at 24 months. At 12 months, BRVA improved in 14 eyes (52%), stabilized in 5 eyes (20%), and decreased in 3 eyes (11%). At 24 months, BRVA improved further in 6 eyes (24%), stabilized in 3 eyes (12%), and decreased in 6 eyes (24 %). Mean CRT decreased from 497 ± 176 to 349 ± 186 μm at 12 months ( p = 0.0005) and to 267 ± 104 μm at 24 months ( p = 0.001). Only five eyes required additional treatment for DME and only three eyes required treatment for raised IOP. Discussion: Our results show that the visual and the anatomical improvements achieved by a single injection of a fluocinolone acetonide implant were maintained up to 24 months with minimal additional therapy even in eyes with a long and heavy history; however, IOP monitoring remains essential.

Effectiveness and tolerability of the fluocinolone acetonide implant in patients with diabetic macular edema in UAE: 12-Month results

Introduction: To evaluate 12-month outcomes following fluocinolone acetonide (FAc 0.2 μg/day) implant in pseudophakic patients with diabetic macular edema (DME) that persists or recurs despite previous treatment with anti-vascular endothelial growth factors (anti-VEGF) and dexamethasone implant (DEX) in a UAE population. Methods: A retrospective, observational, single-center, 12-month audit study, where 22 pseudophakic eyes (22 patients) with DME were treated with the FAc intravitreal implant according to licensed UAE indications. Outcome measurements at baseline and at months 1, 3, 6, and 12 included best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results: Post-FAc implantation, mean BCVA significantly improved at 1, 3, and 12 months (+10.4 ± 16.1, +22.8 ± 13.6, and +25.5 ± 13.0 letters, respectively; p < 0.0001), with 86% of eyes gaining ⩾15 letters at month 12. Similarly, CMT reduced significantly at month 1, and stabilized thereafter at months 3–12 (−171.5 ± 72.5 µm, −240.9 ± 74.2 µm, and −246.2 ± 93.4 µm, respectively; p < 0.0001). By month 12, 64% ( n = 14/22) of eyes had a CMT below 300 µm. Only 1 eye had an IOP ⩾ 21 mmHg at baseline and month 12. Five eyes required IOP lowering drops and 1 required IOP-lowering surgical intervention. Conclusion: In pseudophakic patients with DME FAc implant provide a substantial functional and anatomical benefits for up to 12 months.