Dexamethasone Implant Research Articles

Incidence and Visual Outcomes of Endophthalmitis After Intravitreal Injection of Dexamethasone Implant vs Ranibizumab.

To compare the incidence and visual outcomes of endophthalmitis after injection of an intravitreal dexamethasone implant and injection of intravitreal ranibizumab. This retrospective cohort study assessed endophthalmitis in eyes receiving an intravitreal injection of a 0.7 mg dexamethasone implant (DEX group), 0.5 mg ranibizumab (R5 group), or 0.3 mg ranibizumab (R3 group) between January 1, 2016, and May 31, 2018, at 2 large retina practices in the United States. Suspected endophthalmitis occurred in 5 eyes after 4973 DEX injections, 43 eyes after 163 974 R5 injections, and 6 eyes after 18 954 R3 injections. Suspected endophthalmitis was significantly more common in the DEX group (1/995) than in the R5 group (1/3813) (P = .008) but not than in the R3 group (1/3159) (P = .10). Visual acuity outcomes were similar in the 3 groups. Suspected endophthalmitis might be more common after 0.7 mg dexamethasone injections than after 0.5 mg ranibizumab injections. Culture-positive endophthalmitis rates were similar across all 3 medications.

Intra-Ocular Pressure Response to Dexamethasone Implant Injections in Patients with a History of Filtering Surgery: The TRABEX Study.

Patients with both macular edemas, of various etiologies such as diabetes and glaucoma, may suffer serious loss of vision if either disease goes untreated. Where no effective alternative therapies are available, dexamethasone implant (DEX-I) injections may be the only choice of treatment, despite the risk of a possible increase in intraocular pressure (IOP) when using steroids. Although many studies have reported on IOP evolution in eyes treated with DEX-I, little is known specifically about eyes with a history of filtering surgery. The aim of this observational series was to evaluate the IOP response following DEX-I injection in eyes presenting conventional filtering surgeries or microinvasive glaucoma surgeries (MIGS). Twenty-five eyes were included in this study. A total of 64% of the eyes did not experience OHT during follow-up. Additional IOP-lowering therapy was needed for 32% of eyes, and 20% of eyes (all showing bleb fibrosis) required further filtering surgery: 50% of eyes in the MIGS group and 10.5% of eyes in the conventional filtering surgery group. A significant positive correlation was found between IOP at baseline and the maximum IOP throughout follow-ups after DEX-I (r = 0.45, p = 0.02). In conclusion, if DEX-I is used when there are no alternative therapies for treating macular edema, IOP in eyes with a history of filtering surgery is generally manageable. Those eyes which previously underwent conventional therapy with effective blebs obtained better IOP control after DEX-I injections and mostly did not require any additional IOP-lowering therapy or surgery.

Effect of a Dexamethasone Implant on Rheological Blood Parameters in Patients Treated for Retinal Vein Thrombosis.

PurposeTo assess the effect of the prolonged-release dexamethasone implant (Ozurdex) in patients with retinal venous thrombosis on blood rheological parameters and evaluate the impact on morphological and functional parameters.MethodsProspective cross-sectional study involved 35 subjects treated with central retinal vein and vein branch occlusion with intravitreal dexamethasone implant and 35 healthy subjects in control group. Hematocrit, blood and plasma viscosity, erythrocyte aggregation amplitude (EAA), index (EAI), aggregation half-life time (EAT1/2), and erythrocyte deformability (ED) were evaluated. The best-corrected visual acuity (BCVA), central retinal thickness (CRT) and visual field (VF) were examined. All the parameters were examined at the baseline, 7 and 30 days after the treatment. The results were analyzed with correlation and regression and compared to the baseline values.ResultsIn the studied group, three hemorheological parameters improved as early as on the 7th day after the drug administration, and this improvement remained at a similar level on the 30th day. The EAA increased by 21.26% on day 7 and by 19.78% on day 30, the EAI decreased by 10.55% on day 7 and by 9.14% on day 30 and the EAT1/2 time increased by 38.50% on day 7 and by 31.02% on day 30. On day 7, the BCVA was improved by 1 row, CRT was reduced by 170.77 µm (24.49%), and the VF was improved by 9.8 dB (49.92%) compared to baseline parameters. On day 30, the BCVA was improved by three rows, CRT reduced by 244.68 µm (35.09%), and VF improved by 12.09 dB (61.59%).ConclusionThe intravitreal dexamethasone implant used in treating macular oedema in patients with RVO has a statistically significant effect on some rheological parameters of blood, reduction of CRT and clinical improvement in BCVA and VF.

Foveal eversion patterns in diabetic macular edema

The aim of the present study was to describe foveal eversion patterns in diabetic macular edema (DME) and to assess their relationship with the course of the disease and the outcome. The study was designed as prospective, observational, with two years of follow-up. DME patients were divided in two groups, one treated by combined anti-VEGF injections and dexamethasone (DEX) implants, and the other treated by fluocinolone acetonide (FAc) implant with additional anti-VEGF retreatments if needed. Main outcome measures were foveal eversion prevalence, foveal eversion patterns, best-corrected visual acuity (BCVA), central macular thickness (CMT), structural OCT metrics, number of intravitreal injections. One hundred and forty-six eyes (146 patients; 80 males; mean age 67 ± 8 years) affected by already treated DME, with 84 eyes treated with anti-VEGF/DEX treatments (mean of 10 ± 3 injections) and 62 treated with FAc implant. Looking at the treatments administered before the inclusion into the study, 84 eyes (58%) were treated with anti-VEGF injections, whereas 62 eyes (42%) underwent a combination of anti-VEGF and corticosteroids implants. DME eyes showed statistically significant improvements of LogMAR BCVA and CMT over the 2-year follow-up. Foveal eversion was found in 83 eyes (57%), categorized as follows: Pattern 1a (16;19%); Pattern 1b (22;27%) and Pattern 2 (45;54%). BCVA improvement was detected in all the subgroups, excepting for Pattern 2, which showed also significantly worse structural OCT parameters. Pattern 1b and Pattern 2 were characterized by significantly higher prevalence of persistent DME (64% and 89% of cases, respectively). Foveal eversion patterns were correlated with progressively worse DME outcome. Foveal eversion may be associated to the loss of foveal homeostasis, with consequent poor response to intravitreal treatments and worse DME outcome.

Economic Aspects in the Management of Diabetic Macular Edema in Italy.

BackgroundDiabetic Macular Edema (DME) is the most common cause of vision loss in diabetic patients. Currently, the Vascular Endothelial Growth Factor inhibitors (anti-VEGFs) are used as the first line of DME treatment and corticosteroid implants are usually used as a second-line treatment. These implants are a safe and effective therapeutic option that can improve the quality of life of DME patients by reducing the intravitreal injections number. We determined the economic impact related to DME, also from the social perspective, and the consequences of the increased use of the dexamethasone implant.MethodsThe analysis compares two scenarios: the first based on the current rate of recourse to the therapeutic alternatives available in the Italian healthcare setting (as is) and the second based on the assumption of an increased recourse to dexamethasone implants (to be). The results are expressed both in terms of the resource absorption associated with the two scenarios and in terms of the cost differential yielded by their comparison.ResultsThe increased use of the dexamethasone implant allows considerable savings in terms of healthcare professionals' time, follow-up and productivity lost by patients/caregivers. These savings would reduce healthcare costs for the management of DME patients in Italy by €2,058,238 in 5 years.ConclusionsTo optimize the healthcare resources allocation, it is necessary to implement treatments that yield not only cost reductions but also a clinical benefit for patients. The dexamethasone implant use is an example of DME management that generates value for patients, health system and society.

Results of intravitreal dexamethasone implant (Ozurdex®) for retinal vascular diseases with macular edema: An observational study of real-life situations.

To evaluate the efficacy of intravitreal dexamethasone implants (Ozurdex®) for the treatment of macular edema (ME) associated with retinal vascular diseases in real-life situations.This retrospective study included patients with ME associated with retinal vascular occlusion (RVO) or diabetic macular edema (DME) treated with dexamethasone implants. Demographic data, best-corrected visual acuity (BCVA), and central retinal thickness (CRT) at baseline and at 1, 3, and 6 months postoperatively were collected and analyzed, and the adverse events were recorded.Forty-four eyes, 42 patients were included in the study. The mean logMAR BCVA improved from 0.79 ± 0.38 at baseline to 0.60 ± 0.34 (P < 0.001), 0.72 ± 0.38 (P = .002), and 0.72 ± 0.37 (P = .002) at 1, 3, and 6 months, respectively. The CRT decreased from 526.70 ± 159.58 µm at baseline to 279 ± 66.23, 422.91 ± 206.99, and 350.23 ± 151.51 µm at 1, 3, and 6 months, respectively (P < 0.001, all visits). The average number of injections was 1.43 ± 0.5. Nineteen eyes (43.18%) received second injections at an interval of 4.20 ± 0.61 months. The mean logMAR BCVA was greater in RVO than in DME patients and in treatment-naïve eyes than in previously treated ones. The baseline CRT of the reinjection group was significantly higher than that of the single-injection group for both the RVO (P < 0.001) and DME groups (P = .002). Nine eyes (20.45%) with increasing intraocular pressure (IOP) were well controlled with medication, and cataract progression was observed in five eyes (21.73%) during follow-up.The dexamethasone implant was effective for the treatment of macular edema secondary to RVO and DME in terms of visual acuity and CRT improvement over 6 months. The visual acuity was greater in the RVO and treatment-naïve eyes. Reinjection may be associated with a high baseline CRT. The increase in the occurrence of IOP and cataract progression was similar to that reported in previous studies.

The effect of intravitreal dexamethasone implantation on diabetic macular edema refractory to anti-vascular endothelial growth factor treatment

ABSTRACT Purpose To evaluate the efficacy and safety of intravitreal dexamethasone (DEX) implantation for diabetic macular edema (DME) that proved unresponsive to previous anti-vascular endothelial growth factor (VEGF) treatment. Methods This prospective interventional study recruited 91 patients with refractory DME after previous anti-VEGF treatments in one or both eyes. All patients were followed up for at least 12 months. Best-corrected visual acuity (BCVA), central subfield thickness (CST) and macular volume were measured. Results Over the 12 months, a mean of 2.1 ± 0.8 DEX implantations were administered per eye; 26 eyes (28.9%) received 1 implantation, 31 (34.4%) received 2, and 34 (36.7%) received 3. BCVA was significantly improved in the first 6 months, from 54.8 to 59.5 letters. Both CST and macular volume decreased significantly after DEX implantation and maintained these improvements for at least 12 months. Subjects who needed the second DEX implantation had a greater number of prior anti-VEGF injections than did those who needed only one implantation (6.0 vs 3.0). Conclusions Two-thirds of refractory DME required less than two DEX implantations to maintain a dry macula for 12 months. Early switching to intravitreal DEX can be considered as the second-line therapeutic option, especially during the COVID-19 pandemic.

One-Month Outcomes of Intravitreal Anti-VEGF vs. Dexamethasone Implant in the Treatment of Diabetic Macular Edema in Vitrectomized Eyes.

ObjectivesTo compare short-term effect of intravitreal ranibizumab with dexamethasone implant for diabetic macular edema (DME) in vitrectomized eyes.MethodsSingle-center, prospective, randomized study of vitrectomized eyes with DME. Study eyes were divided into two groups, receiving ranibizumab (IVV group, n = 35 eyes) or dexamethasone implant (IVD group, n = 35 eyes) respectively. Patients were evaluated at baseline, Week 1 and Month 1. The main outcome measures included best-corrected visual acuity (BCVA), central retinal thickness (CRT) and intraocular pressure (IOP).ResultsBCVA and CRT were similar in the two groups at baseline. At Week 1, the CRT improvement was significant in two groups (P = 0.041 in IVV group, P = 0.030 in IVD group), but at Month 1, only IVD group had significant improvement in CRT (P < 0.001). And BCVA gains were significant at Week 1 (P = 0.029) and Month 1 (P = 0.001) in IVD group, whereas IVV group did not show significant BCVA gains (P = 0.056 at Week1, P = 0.166 at Month 1). The changes of BCVA and CRT were significantly higher in IVD group than IVV group at Month1, but the changes were not significant at Week1.ConclusionsComparing to anti-VEGF therapy, DEX implant is more effect in improving BCVA and reducing CRT in vitrectomized eyes at 1 month, which indicated DEX implant is a better strategy.

Optical Coherence Tomography Biomarkers in Predicting Treatment Outcomes of Diabetic Macular Edema After Dexamethasone Implants.

PurposeTo identify optical coherence tomography (OCT) biomarkers that may predict functional and anatomical outcomes in diabetic macular edema (DME) patients treated with intravitreal dexamethasone (DEX) implant.Materials and MethodsSixty-four eyes from 50 patients with DME were enrolled. Best-corrected visual acuity (BCVA) and OCT biomarkers including central retinal thickness (CRT), subretinal fluid (SRF), intraretinal cysts (IRC), ellipsoid zone disruption (EZD), disorganization of retinal inner layers (DRIL), hard exudate (HE), hyperreflective foci (HRF), epiretinal membrane (ERM), and vitreomacular interface (VMI) changes were evaluated at baseline and at 3, 6, and 12 months after treatment. Multiple logistic analysis was performed to evaluate each OCT biomarker as a predictive factor for functional and anatomical improvement at the end of treatment.ResultsThe presence of SRF at baseline was associated with a favorable outcome, with CRT improving by more than 100 μm after treatment from multivariate logistic regression analysis [odds ratio 6.16 (1.75–21.6)]. In addition, baseline SRF predicted a greater CRT improvement from multiple regression analysis (model R-square 0.11, p = 0.006). The reduction of DRIL, SRF, LONLC, IRC, and EZD were correlated with better CRT improvement (more than 100 μm) (P < 0.05). SRF and EZD recovery can also predict better visual prognosis (P < 0.05).ConclusionOCT biomarkers can be used to predict who may benefit the most after DEX treatment. We suggest that the DEX implant should be considered as a first line treatment in DME patients with SRF.

CLINICAL FEATURES OF INTRAVITREAL DEXAMETHASONE IMPLANTATION IN VITRECTOMIZED EYES OF PATIENTS WITH DIABETIC MACULAR EDEMA.

To identify the clinical outcomes of intravitreal dexamethasone implantation (IVD) in previously vitrectomized eyes of patients with diabetic macular edema. We performed a retrospective observational study. We recorded central subfield thickness, best-corrected visual acuity, and intraocular pressure up to 12 months after IVD implant placement. We compared the duration of IVD action, intraocular pressure trends, and the prevalence of ocular hypertension after the first IVD treatment of nonvitrectomized and vitrectomized eyes. We also compared the central subfield thickness, best-corrected visual acuity, number of IVD treatments, and prevalence of ocular hypertension between the 2 groups after 12 months. We found no significant between-group differences in the central subfield thickness, best-corrected visual acuity, or the prevalence of ocular hypertension during treatment. However, the duration of action of the first IVD treatment was significantly shorter in vitrectomized eyes, and these eyes required more IVD treatments during the 12-month follow-up period. The maximal average intraocular pressure was observed at 2 months after the first IVD treatment in the nonvitrectomized group, but 1 month after the first IVD treatment in the vitrectomized group. These findings suggest that the IVD pharmacokinetics and pharmacodynamics differ between vitrectomized and nonvitrectomized eyes. Nevertheless, given the relatively long-lasting effectiveness of the treatment and the good clinical results, consecutive IVD treatments may be beneficial for patients with diabetic macular edema with previously vitrectomized eyes.

Treatment of diabetic macular edema with intravitreal DEX Implant in Germany: Efficacy and safety in naïve and pre-treated patients in clinical practice.

To investigate the efficacy and safety of dexamethasone (DEX) implant in eyes with diabetic macular edema (DME) over 12-months. In this retrospective study charts from a single center were analysed, including naïve and pre-treated patients. Best corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated at baseline, months 1-2, 3-4, 5-6 and 7-12. Data of 77 eyes were analysed (58.4% were pre-treated with anti-VEGF inhibitors). Mean baseline BCVA values for the whole sample, pre-treated and naïve patients, were 60.94 (SD 13.74), 60.85 (SD 13.80) and 61.01 (SD 13.86) letters, respectively. In the whole sample BCVA changes against baseline were significant (p < 0.05) at months 1-2, 3-4 and 7-12. In the pre-treated group changes were statistically significant at months 1-2 and 7-12. No statistically significant differences were found in the naïve group and between subgroups.In the whole group and the pre-treated group, CRT changes against baseline were significant (p < 0.05) at all time points, while in the naïve group changes were only significant at time point months 3-4. No statistically significant differences were found between subgroups.IOP increases were moderate and successfully managed with topical medication. After treatment with DEX implant, BCVA increased and CRT decreased significantly in the whole population at all time points. No significant differences were found between naïve and pre-treated patients. Changes in BCVA and CRT in the naïve group were not statistically significant. This was most likely attributable to the small sample size. The data underlines the importance of DEX implant as an efficacious and safe alternative to VEGF- inhibitors in real world practice.

Efficacy and Safety of Intravitreal Fluocinolone Acetonide Implant for Chronic Diabetic Macular Edema Previously Treated in Real-Life Practice: The REALFAc Study.

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients and a chronic disease requiring long-term treatments. The fluocinolone acetonide (FAc) implant has recently been approved to treat DME in patients considered insufficiently responsive to available therapies. This study evaluates the functional and anatomical efficacy of the FAc implant in real-life practice. A total of 62 eyes with chronic DME were included and followed for a mean of 13.9 (+7.5) months. Previous treatment included at least anti-vascular endothelial growth factor (VEGF) in 83.9% of eyes, dexamethasone implant (DEX-I) in 100% of eyes, vitrectomy in 29.0% of eyes, and laser photocoagulation (either panretinal or focal photocoagulation) in 75.8% of eyes. The mean baseline best corrected visual acuity (BCVA) was 64.0 (+/−17.2) letters (median: 67.5 letters) with a mean DME duration of 60.3 (+/−30.6) months. The maximum BCVA gain occurred at 21 months with a mean gain of 5.0 (+/−12.7) letters. A total of 50.0% of eyes gained ≥5 letters during follow-up. Patients with lower BCVA at baseline had the lowest final BCVA (p < 0.001) but the highest BCVA gain (p = 0.02). The best overall improvement in mean central macular thickness (CMT) occurred at 18 months (p < 0.0001). The improvement in BCVA was inversely associated with the decrease in CMT and showed a decrease when CMT increased (DME recurrence). According to the history of vitrectomy, we did not find any significant difference in mean final BCVA (p = 0.1) and mean BCVA gain (p = 0.2) between eyes previously vitrectomized or not. A total of 23 eyes (37.1%) required additional treatment for DME, and 17.7% required an IOP-lowering procedure during follow-up. In conclusion, this real-life observational study demonstrated the efficacy and safety of the FAc implant in patients with chronic DME already treated with other available therapies.

Optical coherence tomography and imaging biomarkers as outcome predictors in diabetic macular edema treated with dexamethasone implant

In this retrospective, multicenter study, we determined the predictive value of imaging biomarkers in diabetic macular edema (DME) outcomes following dexamethasone (DEX) implant(s). Sixty-seven eyes of 47 patients’ best-corrected visual acuity (BCVA) and central foveal thickness (CFT) on optical coherence tomography (OCT) before and after intravitreal DEX implants were evaluated. Baseline imaging biomarkers were graded using fundus photography and OCT, and the predictive value of biomarkers for significant treatment effects at six months was analyzed. Six months after 2.0 ± 0.8 (mean ± SD) DEX implants, 35 (52%) and 16 (24%) eyes had CFT reduction ≥ 10% from baseline and decreased to < 300 µm, respectively. BCVA improved ≥ 3 lines in 15 (22%) and remained stable in 38 (57%) eyes. At six months, eyes with severe intraretinal cyst (IRC), abundant hyperreflective dots (HRD), and moderate or severe hard exudate had a significantly higher chance of CFT reduction ≥ 10%. Eyes with abundant HRD at baseline and those underwent three DEX implants were more likely to achieve CFT < 300 µm. Eyes with DME and severe IRC, abundant HRD, or moderate-to-severe hard exudate at baseline were more likely to show a significant reduction in CFT six months after DEX implant.

Mid-term safety and effectiveness of intravitreal dexamethasone implant to treat persistent cystoid macular edema in vitrectomized eyes for bacterial endophthalmitis.

To evaluate the mid-term safety and effectiveness of intravitreal dexamethasone implant (DEX-i) for treating unresponsive to medical therapy cystoid macular edema (CME) in vitrectomized eyes for endophthalmitis. Retrospective and interventional case series study conducted on vitrectomized eyes for endophthalmitis that developed a CME that did not adequately respond to medical therapy, who underwent 0.7-mg DEX-i. Main outcome measures were changes in central retinal thickness (CRT) and best corrected visual acuity (BCVA). Eleven eyes were included in the study. Microbiological findings of vitreous biopsies were 7 (63.6%) staphylococcus epidermidis; 3 (27.3%) Pseudomonas aeruginosa; and 1 (9.1%) Propionibacterium acnes. Median (interquartile range, IqR) duration of CME was 4.0 (3.0-4.0) months. Median (IqR) time between vitrectomy and DEX-i was 9.0 (9.0-11.0) months. Median CRT was significantly decreased from 548.0 (412.8-572.5) µm at baseline to 308.0 (281.3-365.5) µm at month 6 (p = 0.0009, Friedman test). Median BCVA significantly improved from 38.0 (30.5-44.8) letters at baseline to 50.0 (46.8-53.0) letters at month 6 (p < 0.0001, Friedman), with 9 (81.8%) eyes gaining ≥ 10 letters. Elevation of intraocular pressure was observed in one (9.1%) eye, which was successfully controlled with medical therapy. No recurrence of endophthalmitis or other complications was observed. Eight (72.7%) eyes required an additional DEX-i, while 3 (27.3%) were successfully controlled with only one DEX-i. CME recurrence occurred in 5 (62.5%) Gram-positive and 3 (100.0%) Gram-negative bacteria (p = 0.2357). In vitrectomized eyes for endophthalmitis affected by CME unresponsive to medical therapy, DEX-i had an acceptable safety profile and achieved favorable outcomes. The possibility of suppressing mechanisms for infection control should be taken into account, although correct management of endophthalmitis and long time without reactivation before DEX-i reduce the risk.

Risk factors in developing retinal vein occlusion in subject with obstructive sleep apnea.

Patients with obstructive sleep apnea (OSA) have a higher risk of developing vascular diseases. In this study, we evaluated the clinical profile of patients with OSA who develop retinal vein occlusion (RVO) compared with a population of OSA patients without RVO. We analyzed patients with OSA diagnosed with RVO (21 cases; mean of age 61 years. range 44-87 years. 67% men), belonging to a large cohort of people with long-term follow-up for RVO (up to 12 years). We compared them with 21 patients with OSA, without RVO, matched by age and gender, selected from the Sleep Unit Registry (control group). There were no differences in the prevalence of arterial hypertension (AHT) or Diabetes mellitus (DM), but the RVO patients presented a higher diastolic blood pressure compared to controls (87.6±12.6 mmHg vs. 77.9±10.1 mmHg respectively). The polygraphic parameters were similar in both groups. The Apnea-Hypopnea Index (IHA) similar in both groups (30.4±20.9 RVO vs. 33.7±22.1 controls). In addition, RVO patients had a less favorable lipid profile, with higher total cholesterol (218±52 mg/dL vs. 179±41 mg/dL), higher LDL cholesterol (139±47 mg/dL vs. 107±32 mg/dL) and higher atherogenic indices: LDL/HDL (2.78±0.95 RVO vs. 2.03±0.67 controls) and total cholesterol/HDL (4.37±1.08 vs. 3.45±0.84). Among the cases, 81% had peripheral RVO (superior temporal branch in 20 out of 21 cases) and 19% had central RVO. A percentage of 62% of the cases received intravitreal antiangiogenic therapy and dexamethasone implants and 33% received argon laser photocoagulation. Poor control of cardiovascular risk factors, particularly dyslipidemias, in patients with OSA may lead to the development of this ocular complication.

The Efficacy of Simultaneous Injection of Dexamethasone Implant and Ranibizumab Into Vitreous Cavity on Macular Edema Secondary to Central Retinal Vein Occlusion.

The purpose of this study was to determine the safety and effectiveness of simultaneous vitreous injection of dexamethasone implant and ranibizumab on macular edema secondary to central retinal vein occlusion (CRVO). We conducted a 6-month retrospective self-control study. Twenty-five patients diagnosed with macular edema secondary to CRVO were enrolled in this study. The patients received intravitreal injection of dexamethasone implant and ranibizumab. The changes in best corrected visual acuity (BCVA), central retinal thickness (CRT) and interocular pressure (IOP) before and at 2w, 1, 2, 3, 4, 5, 6 m after injection were recorded and compared. The adverse reactions in eyes and whole body were observed. The BCVA of all patients at 2 w (61.8 ± 5.42), 1 m (68.68 ± 5.23), 2 m (70.8 ± 5.8), 3 m (68.44 ± 5.61), 4 m (65.76 ± 5.76), 5 m (67.08 ± 5.57), and 6 m (70.12 ± 5.46) after surgery were significantly higher than that before surgery (52.2 ± 5.06,p < 0.01), and CRT of all patients at 2w (393.36 ± 52.66 um), 1 m (334.52 ± 32.95 um), 2 m (298.800 ± 29.97 um), 3 m (309.080 ± 28.78 um), 4 m (345.48 ± 39.81 um), 5 m (349.080 ± 29.88 um), and 6 m (309.76 ± 30.41 um) after surgery were significantly reduced than that before surgery (583.76 ± 121.09 um, p < 0.01). Macular edema recurred in an average of 4.44 ± 0.51 months after treatment, and those patients received combined treatment again. During follow-up, the most common adverse reactions were subconjunctival hemorrhage and increased intraocular pressure, with the incidence of 22% (11/50) and 18% (9/50) respectively. In all cases, the increased intraocular pressure could be controlled by a single intraocular pressure reducing drug. No patient needed to receive anti-glaucoma surgery. The overall incidence of lens opacity was 4% (2/50). After the first injection, no case showed lens opacity. After re-injection, 2 patients (2 eyes) (8%) developed lens opacity. None of the patients showed serious ocular adverse reactions or systemic complications such as vitreous hemorrhage, retinal detachment, endophthalmitis, uveitis or ocular toxicity. The simultaneous vitreous injection of dexamethasone implant and ranibizumab can significantly improve the visual acuity and anatomical prognosis in macular edema secondary to central retinal vein occlusion (CRVO-ME) patients, exhibiting good safety and effectiveness.

Dexamethasone Implant for Diabetic Macular Oedema: 1-Year Treatment Outcomes from the Fight Retinal Blindness! Registry.

IntroductionPhase III clinical trials of dexamethasone intravitreal implant for diabetic macular oedema (DMO) have reported significant improvements in visual acuity (VA). Studies evaluating the treatment of DMO in routine clinical practice provide data to identify areas that need improvement. This study evaluated 12-month treatment outcomes of dexamethasone implant for DMO in routine clinical practice.MethodsRetrospective data analysis of eyes that started dexamethasone implant for DMO from 1 June 2013 to 30 April 2019 in routine clinical practice tracked in the Fight Retinal Blindness! Registry.ResultsOf the 4282 eyes (2518 patients) that started DMO treatment in the specified period, 267 (6%) eyes (204 patients) received 454 dexamethasone implant injections. Two-fifths (106 eyes) had received prior treatment for DMO. The mean (95% confidence interval [CI]) VA change at 12 months was 1.8 (− 0.5, 4.2) letters from the mean (standard deviation [SD]) VA of 56.5 (19.8) letters at baseline, with 41% eyes achieving at least 20/40. The mean (95% CI) change in central subfield thickness over 1 year was − 79 (− 104, − 54) µm from a mean (SD) of 459 (120) µm at baseline. Eyes that completed 1 year of follow-up received a median (Q1, Q3) of 2 (1, 2) dexamethasone implants. One-tenth of phakic eyes received cataract surgery while 2% had a pressure response requiring anti-glaucoma medications.ConclusionsOne-year treatment outcomes of dexamethasone intravitreal implant for DMO in routine clinical practice were inferior to those in the clinical trials perhaps because of fewer treatments in clinical practice.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-022-00473-3.

OCT-Angiography Changes in Patients with Diabetic Macular Edema Treated with Intravitreal Dexamethasone Implant.

PurposeTo evaluate, using optical coherence tomography angiography (OCTA), the impact of intravitreal dexamethasone (DEX) implant on quantitative vascular measurements in patients with diabetic macular edema (DME).MethodsProspective, randomized, and open-label study. Primary endpoints were mean changes in vessel density (VD) and vascular perfusion (VP) in superficial capillary plexus (SCP) and VP in deep capillary plexus (DCP) and peripapillary capillary plexus (PCP).ResultsThirty-four eyes from 19 patients were included. Mean age was 67.4±7.3 years and 24 (76.5%) were men. VD in SCP in the 6 mm × 6 mm perifoveal ring was significantly decreased from 15.2±2.7 mm/mm2 at baseline to 13.5±3.1 at month-2, p, 0.0029. VP in SCP in the 6 mm × 6 mm perifoveal ring decreased significantly from baseline to month-2 (mean change −3.8%; 95% confidence-interval: −7.7% to −1.7%, p, 0.0028). Compared to baseline, the VP in DCP was significantly reduced at month 2 in the perifoveal ring of the 6 mm × 6 mm scan (p, 0.0063), and in the parafoveal ring of the 6 mm × 6 mm scan (p, 0.0048). Foveal avascular zone (FAZ) area did not change throughout the study. Central macular thickness significantly decreased from baseline in 210.3 µm (149.9–270.8 µm) and 201.8 µm (140.4–263.3 µm), p < 0.0001 each at month-2 and month-3, respectively.ConclusionsBesides functional and anatomical improvements, DEX implant significantly reduced VD and VP in DME patients.

Prospective evaluation of the effectiveness of combined treatment of macular edema secondary to retinal vein occlusion with intravitreal bevacizumab and dexamethasone implants.

To evaluate the effectiveness of in---travitreal bevacizumab injections following a single dexamethasone implant in the treatment of macular edema secondary to branch and central retinal vein occlusion. This was a prospective interventional non-comparative study, 44 eyes of patients with naïve macular edema related to branch and central retinal vein occlusion were treated with a dexamethasone implant. Patients were followed-up at four-week intervals from the second to the sixth month. If persistent or recurrent macular edema occurred during this period, the patient was treated with intravitreal bevacizumab injections on an as-needed basis. The outcome measures were best-corrected visual acuity and central macular thickness changes. The mean best-corrected visual acuity changed from 0.97 ± 0.33 LogMAR at baseline to 0.54 ± 0.40 at the six-month post-implant examination (p<0.00001). Improvement ≥3 Snellen lines were seen in 20 eyes (45.54%). The mean central macular thickness at baseline was 670.25 ± 209.9 microns. This had decreased to 317.43 ± 112.68 microns at the six-month follow-up (p<0.00001). The mean number of intravitreal bevacizumab injections received in the six months post-implant was 2.32. The mean time from dexamethasone implant to first anti-VEGF injection was 3.45 months. Intravitreal bevacizumab injections following a single dexamethasone implant were found to improve best-corrected visual acuity and central macular thickness in patients with macular edema due to branch and central retinal vein occlusion at six months, with few intravitreal injections required.

Optical Coherence Tomography Angiographic Evaluation of Macular Vessel Density in Diabetic Macular Edema after Intravitreal Dexamethasone Implants: A Prospective Interventional Trial

Optical Coherence Tomography Angiographic Evaluation of Macular Vessel Density in Diabetic Macular Edema after Intravitreal Dexamethasone Implants: A Prospective Interventional Trial