Abstract
Introduction: The effectiveness and safety of the fluocinolone acetonide (FAc) implant was evaluated at Month 24 and, in some sustained for up to 36 months, in patients with diabetic macular edema (DME) and a pseudophakic lens treated in the UAE following prior anti-vascular endothelial growth factor and dexamethasone (DEX) implant. Methods: This was a retrospective, observational audit study conducted between September 2017–September 2020 in which 22 patients were treated with the FAc implant and outcomes monitored for up to 36 months. Effectiveness outcomes were: best-corrected visual acuity (BVCA) and central macular thickness (CMT). Safety was assessed by monitoring intraocular pressure (IOP). All outcomes were measured at Months 1, 3, 6, 12, 24, and 36. Results: Significant improvements in mean BCVA were observed versus baseline from Month 1, which were maintained up to Month 24 (P < 0.0001 versus baseline). In all five patients completing 36 months follow-up, the improvements in BVCA were maintained through to Month 36 P < 0.005 versus baseline. Similarly, mean CMT improved versus baseline at Month 1 through to Month 24 (P < 0.0001 versus baseline), with significant improvements also noted in the 5 patients completing 36 months follow-up (P < 0.005 versus baseline). An IOP rise to 32 mmHg was observed in one eye, but returned to normal values at next measure. Five eyes required IOP lowering drops and one required IOP-lowering surgical intervention. Conclusion: The FAc intravitreal implant is effective for 24 months, and sustained for 36 months, in a UAE population previously treated with a DEX implant, with tolerability profile in-line with previous reports.
| Original language | English |
|---|---|
| Pages (from-to) | 1068-1076 |
| Number of pages | 9 |
| Journal | European Journal of Ophthalmology |
| Volume | 33 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 2023 |
Keywords
- Diabetic macular edema
- NCT03590587
- Registry details ClinicalTrials.gov
- anti-inflammatory agents
- diabetic retinopathy
- fluocinolone acetonide implant
- https://clinicaltrials.gov/ct2/show/NCT03590587
- intravitreal corticosteroids
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