PMID- 34667735 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211022 IS - 2222-3959 (Print) IS - 2227-4898 (Electronic) IS - 2222-3959 (Linking) VI - 14 IP - 10 DP - 2021 TI - Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes. PG - 1571-1580 LID - 10.18240/ijo.2021.10.15 [doi] AB - AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex((R))/DEX) in patients with diabetic macular edema (DME) either naive or non-naive to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs). METHODS: This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naive to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naive before receiving DEX implant, was collected. RESULTS: Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naive compared to non-naive patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported. CONCLUSION: This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naive patients. CI - International Journal of Ophthalmology Press. FAU - Neves, Pedro AU - Neves P AD - Department of Ophthalmology, Centro Hospitalar de Setubal, Setubal 2910-549, Portugal. FAU - Ornelas, Mario AU - Ornelas M AD - Department of Ophthalmology, Centro Hospitalar de Setubal, Setubal 2910-549, Portugal. FAU - Matias, Ines AU - Matias I AD - Department of Ophthalmology, Centro Hospitalar de Setubal, Setubal 2910-549, Portugal. FAU - Rodrigues, Joao AU - Rodrigues J AD - Department of Ophthalmology, Hospital Beatriz Angelo, Loures 2674-514, Portugal. FAU - Santos, Margarida AU - Santos M AD - Department of Ophthalmology, Hospital da Luz Setubal, Setubal 2900-722, Portugal. FAU - Dutra-Medeiros, Marco AU - Dutra-Medeiros M AD - Department of Ophthalmology, Centro Hospitalar Lisboa Central, Faculdade de Ciencias Medicas, NOVA University of Lisbon, Lisbon 1990-237, Portugal. FAU - Martins, David AU - Martins D AD - Department of Ophthalmology, Hospital da Luz Setubal, Setubal 2900-722, Portugal. LA - eng PT - Journal Article DEP - 20211018 PL - China TA - Int J Ophthalmol JT - International journal of ophthalmology JID - 101553860 PMC - PMC8482000 OTO - NOTNLM OT - anti-VEGF therapy OT - dexamethasone intravitreal implant OT - diabetic macular edema OT - naive eyes OT - steroids EDAT- 2021/10/21 06:00 MHDA- 2021/10/21 06:01 PMCR- 2021/10/18 CRDT- 2021/10/20 06:46 PHST- 2020/07/24 00:00 [received] PHST- 2021/01/05 00:00 [accepted] PHST- 2021/10/20 06:46 [entrez] PHST- 2021/10/21 06:00 [pubmed] PHST- 2021/10/21 06:01 [medline] PHST- 2021/10/18 00:00 [pmc-release] AID - ijo-14-10-1571 [pii] AID - 10.18240/ijo.2021.10.15 [doi] PST - epublish SO - Int J Ophthalmol. 2021 Oct 18;14(10):1571-1580. doi: 10.18240/ijo.2021.10.15. eCollection 2021.