Visual Acuity Gain Profiles and Anatomical Prognosis Factors in Patients with Drug-Naive Diabetic Macular Edema Treated with Dexamethasone Implant: The NAVEDEX Study.

The purpose of this study is to evaluate the visual acuity (VA) gain profiles between patients with drug-naive diabetic macular edema (DME) treated by dexamethasone implant (DEX-implant) and assess the baseline anatomical and functional factors that could influence the response to the treatment in real-life conditions. A retrospective, multi-center observational study included 129 eyes with drug-naive DME treated by DEX-implant. The Median follow-up was 13 months. Two groups of VA gain trajectories were identified-Group A, with 71% (n = 96) of patients whose average VA gain was less than five letters and Group B, with 29% (n = 33) of patients with an average gain of 20 letters. The probability of belonging to Group B was significantly higher in patients with baseline VA < 37 letters (p = 0.001). Ellipsoid zone alterations (EZAs) or disorganization of retinal inner layers (DRILs) were associated with a lower final VA (53.0 letters versus 66.4, p = 0.002) but without a significant difference in VA gain (4.9 letters versus 6.8, p = 0.582). Despite a low baseline VA, this subgroup of patients tends to have greater visual gain, encouraging treatment with DEX-implant in such advanced-stage disease. However, some baseline anatomic parameters, such as the presence of EZAs or DRILs, negatively influenced final vision.

LONG-TERM INCIDENCE AND RISK FACTORS OF OCULAR HYPERTENSION FOLLOWING DEXAMETHASONE-IMPLANT INJECTIONS: THE SAFODEX-2 STUDY.

PURPOSE: To analyze the incidence, risk factors, and time to onset of ocular hypertension (OHT) after intravitreal injections (IVI) of dexamethasone implant and to evaluate the long-term cumulative probability of intraocular pressure elevation. METHODS: Eyes of patients having received at least one dexamethasone implant IVI between October 2010 and February 2015 were included in the present study. Ocular hypertension was defined as intraocular pressure > 25 mmHg and/or an increase of 10 mmHg over the follow-up period compared with baseline intraocular pressure. RESULTS: Four hundred ninety-four eyes were studied in 410 patients. For a total of 1,371 IVI, the incidence of OHT was 32.6% in the study eyes with a mean follow-up period of 30 months (3-62.5) and a median follow-up of 29 months. Pressure-lowering treatment was introduced for 36.9% of eyes. Topical treatment alone was sufficient to manage OHT in 97%. Young age, male sex, uveitis and retinal vein occlusion, and glaucoma treated with a double- or triple-combination topical pressure-lowering medication were found to be risk factors for OHT. The incidence of OHT did not change with an increase in the number of IVI, and there was no cumulative effect, defining by an increase of the incidence of OHT in patients after repeated IVI (P = 0.248). CONCLUSION: This study confirmed that OHT is of moderate incidence, transient, controlled by topical treatment and provides data on the long-term cumulative probability of intraocular pressure elevation in a large cohort of eyes treated with dexamethasone implant IVI. Repeat injections of dexamethasone implant neither increase nor decrease the risk of OHT.

Long-term follow-up of diabetic macular edema treated with dexamethasone implant: a real-life study.

AIMS: To evaluate the efficacy and safety of intravitreal dexamethasone implant (DEX-implant) for diabetic macular edema (DME) in real-life practice with an extended follow-up for up to 5 year. METHODS: This multicentric retrospective study reviewed 227 eyes of 152 patients with DME treated by DEX-implant. Main outcome measures included changes in best corrected visual acuity (BCVA), central macular thickness (CMT), time to retreatment and incidence of adverse effects. RESULTS: The mean number of DEX-implant received by patients was 2.6 (± 2.2) with a mean (SD) follow-up of 20.1 (± 15.8) months, median [IQR] 15.8 [7.4-30.1]. The mean time of retreatment was 6.9 months. The mean maximal BCVA gain during follow-up was 12.3 (± 12.7) letters. A gain of ≥ 5, ≥ 10 and ≥ 15 letters from baseline BCVA was obtained for 71.8%, 48.9% and 34.8% of eyes, respectively. A total of 62.6% of eyes presented a significant anatomical response (decrease of CMT ≥ 20%), and DME was resolved (absence of cystoid macular spaces on OCT) in 37% of cases at the end of the follow-up. A transient increase in intraocular pressure ≥ 25 mmHg occurred in 14.1% of eyes, and cataract surgery was performed for 49.1% of the phakic eyes during the follow-up. Four eyes developed a proliferative diabetic retinopathy. CONCLUSION: This large cohort study showed favorable long-term outcomes when using DEX-implant, which provides substantial long-term benefits in the treatment of DME in real life.

Long-Term Intravitreal Dexamethasone Treatment in Eyes with Pretreated Chronic Diabetic Macular Edema.

PURPOSE: The aim of this study is to assess the effect of repeated injections of dexamethasone implants in patients with persistent diabetic macular edema (DME) despite prior therapies. METHODS: This retrospective interventional study involved 47 DME-afflicted eyes, which were administered ≥2 intravitreal injections of dexamethasone. Group 1 (34 eyes) received a dexamethasone monotherapy, whereas group 2 (13 eyes) received a combination therapy with intravitreal antivascular endothelial growth factor as needed. The duration of dexamethasone effect until retreatment and the change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were defined as outcome measures. RESULTS: A total of 197 injections of dexamethasone were administered in group 1 and 52 in group 2 during a mean follow-up of 23 ± 10 and 24 ± 13 months, respectively. Mean time to reinjection was 4.6 ± 0.5 (group 1) and 5.3 ± 1.0 months (group 2; P = 0.17). Reinjection intervals did not shorten over time for up to 10 dexamethasone injections per eye in group 1 and BCVA improved from before 1 month after the first implantation, 7.0 letters (P = 0.04). In group 2, there was no significant improvement in BCVA at any time point. CRT decreased from 534 ± 208 and 529 ± 215 µm to 287 ± 115 and 371 ± 78 µm at 3 months and increased to 460 ± 186 µm and 547 ± 175 µm before reinjection (groups1 and 2, respectively). The maximal CRT before each implantation remained stable over time. CONCLUSIONS: In eyes with chronic DME that respond incompletely to prior therapy or require frequent reinjections, dexamethasone shows promising long-term anatomic and functional improvement. The absence of a treatment effect reduction over time argues against a relevant rebound phenomenon.