DEX Implant Research Articles

Implantable intravitreal corticosteroids in chronic noninfectious uveitis

Uveitis leads to blindness in 10-15% of all cases in industrialized nations. The prevalence varies depending on the literature, ranging from 9to 730 cases per 100,000 inhabitants. Local and systemic steroid applications, along with treatment involving immunomodulators, are the primary treatment options. In cases of chronic and refractory uveitis, especially with the manifestation of uveitic macular edema, intravitreal corticosteroids can contribute to reduce or completely replace systemic immunomodulatory therapy with disease-modifying antirheumatic drugs (DMARDs), biologics or corticosteroids. This review article presents the currently available intravitreal corticosteroid implants used in the treatment of noninfectious uveitis. The indications, effectiveness, and side effect profiles are discussed within the context of the current literature. A total of 6randomized controlled studies about FAc and DEX implants with more than 100 patients were included in this review. One subgroup analysis from amulticentric randomized study with 315 patients has been included as well. The outcome is discussed in this article. The efficacy and safety profile of intravitreal corticosteroids in uveitic macular edema have been evaluated in several studies in recent years. In some studies, they have been compared to systemic treatment options. With long-acting corticosteroid implants the number of relapses can be reduced and the time interval between relapses can be prolonged. Short-acting corticosteroid implants represent atreatment option during acute uveitic activity. The adverse effects of corticosteroids can be well-controlled in most cases. In phakic and/or young patients, however, adverse effects (such as cataract development) should be discussed in depth before treatment initiation as most corticosteroids are applied as long-term treatment.

Intravitreal DEX Implant for the Treatment of Diabetic Macular Edema: A Review of National Consensus.

Diabetic macular edema (DME)'s therapeutic approach can frequently be challenging. The purpose of the review is to propose evidence-based recommendations on the employment of intravitreal dexamethasone implants (DEX) when approaching patients suffering from DME. Seven national consensuses redacted by different groups of retina specialists from Europe and Asia were examined and confronted. Each consensus was redacted utilizing a Delphi approach, in person meetings, or by reviewing the literature. DEX can be studied as a first-line strategy in individuals suffering from DME with inflammatory OCT biomarkers, in vitrectomized eyes, in patients with recent cardiovascular events, in pregnant women, in patients scheduled to undergo cataract surgery or with poor compliance. The other parameters considered were the indications to the DME treatment, when to switch to DEX, the definition of non-responder to anti-VEGFs agents and to the DEX implant, whether to combine DEX with laser photocoagulation, the association between glaucoma and DEX, and the management of DEX and the cataract. Although several years have passed since the introduction of DEX implants in the DME treatment, there is still not a unified agreement among retina specialists. This paper compares the approach in the DME treatment between countries from different continents and provides a broader and worldwide perspective of the topic.

Comparison of Intravitreal Dexamethasone Implant and Posterior Subtenon Triamcinolone Injection in the Treatment of Diabetic Macular Edema in Vitrectomized Eyes

Introduction: The aim of this study was to compare posterior subtenon triamcinolone (PSTA) application and intravitreal dexamethasone phosphate (DEX) implant in the treatment of diabetic macular edema (DME) in vitrectomized eyes. Methods: This retrospective study included 64 (48.12%) patients who received PSTA and 69 (51.88%) patients who received DEX implants in DME treatment after vitrectomy. Best corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were analyzed before injection; at 1, 3, and 6 months after injection. The postinjection values were statistically compared with the preinjection value. Results: All postinjection CMT values in both groups were lower than the preinjection value (p < 0.05 for all). There were statistically significant increases in all postinjection BCVAs of the DEX group and postinjection 1-month BCVA of the PSTA group (p < 0.05 for all). However, there was no significant difference in BCVA values of the PSTA group at 3 and 6 months after injection (p > 0.05 for both). There was no statistically significant difference in all postinjection IOP values of the PSTA group (p > 0.05 for all). However, significant increases in IOP were observed in the DEX group at 1 and 3 months after injection (p < 0.05 and p = 0.02, respectively). The number of additional injections between the 3rd and 6th months after the initial injection was statistically higher in the PSTA group (p = 0.006). Conclusion: Both intravitreal DEX and PSTA administration are effective in the treatment of DME after vitrectomy. However, visual improvement persisted longer, and the need for additional injections was less in patients who received DEX.

Comparing the Efficacy of Intravitreal Dexamethasone and Time-displaced Fluocinolone Acetonide on Central Retinal Thickness in Patients with Uveitis

ABSTRACT Background To compare the efficacy of intravitreally administered dexamethasone (Dex) and subsequent time-displaced fluocinolone acetonide (FA) on central subfield thickness (CST) in eyes with noninfectious uveitis. Methods Retrospective analysis of twenty-three eyes (18 patients) subsequently receiving intravitreal Dex and FA implants. The main outcome measures were CST, best-corrected visual acuity (BCVA), intraocular pressure (IOP), and status of inflammation. Results CST (Dex: p < .0001; FA: p = .0008) and BCVA (Dex: p = .0009; FA: p = .0005) improved significantly with both implants. Significantly better effects were noted with Dex for absolute and relative CST reduction (p = .0089 and p = .0051, respectively). Final BCVA did not differ between groups (p = .1893). Dex significantly increased IOP, whereas FA did not. One eye was actively inflamed after Dex and FA injection at follow-up (inflamed eyes before injection: [Dex: 2; FA: 6]) Conclusion Both implants significantly reduced CST and induced a significant gain in visual acuity. Dex might be more effective in reducing CST.

Intravitreal dexamethasone implant for noninfectious uveitis in Chinese patients

To evaluate the effectiveness and safety of the dexamethasone intravitreal implant (DEX-I) in Non-Infectious Uveitis (NIU) in Chinese patients. Ninety-one eyes of 77 patients (56 men, 21 women) receiving 130 implant injections for NIU were included. Treatment indication, uveitis diagnosis, best-corrected visual acuity (BCVA), central retinal thickness (CRT), vitreous haze score, intraocular pressure, phakic status, number of injections, time to reinjection, and systemic treatments were collected at baseline, 1week, 1month, 3 and 6months after treatment. All patients were followed for at least 12weeks and had a mean follow-up period of 5.1months (range, 3-14months) after the first implant. The main treatment indications were macular edema (ME), retinal vasculitis, retinal vasculitis with ME. Sixty-one eyes (67.03%) received only one injection, while 31 eyes (32.97%) received two or more. In eyes that received 2 injections, the mean time to the second injection was 3.83months and in those that received 3 injections, the mean time to the third injection was 7.5months. BCVA and CRT significantly improved at 1week, 1month, 3months, and 6months after treatment. When compared to baseline, the mean prednisone (or equivalent) dosage significantly decreased at 3- and 6-month follow-up evaluations after DEX implantation.14.29% of eyes developed a transient increase in intraocular pressure, and a cataract was removed from 1 phakic eye. DEX implants, either alone or in combination with common adjunctive NIU treatments, is safe and effective in the treatment of NIU in Chinese patients.

Impact of Different Clinical Baseline Characteristics on Intravitreal Dexamethasone Implant Ozurdex® Outcomes.

PurposeTo determine the impact of different baseline clinical characteristics on the improvement in best corrected visual acuity (BCVA) in patients with diabetic macular edema (DME) who underwent the intravitreal dexamethasone implant (DEX) Ozurdex®.MethodsThis was a single center retrospective study conducted on patients with DME, either naïve or previously treated, who were treated with one or more DEX and had a follow-up of at least 6 months. The main outcome measure was the proportion of DEX achieving an improvement ≥15 letters in BCVA.ResultsThe study analyzed 192 DEX implants administered to 97 eyes (65 patients). Among the 192 DEX analyzed, 57 (29.7%) implants achieved a BCVA improvement ≥15 letters (ETDRS) from baseline, with a mean time for achieving such improvement of 89.2 (39.7) days. Eyes who received an additional DEX and those with a duration of DME < 6 months had a greater probability of achieving a BCVA improvement ≥15 letters (odds-ratio: 2.55, p = 0.0028 and odds-ratio: 1.93, p = 0.0434). The mean (standard deviation) change in BCVA from baseline was 7.5 (14.5) letters, p < 0.0001. The mean change in central macular thickness (CMT) from baseline was −128.0 (151.0) µm, p < 0.0001. The mean number of DEX implanted was 1.9 (0.8). Four (2.1%) DEX experienced an intraocular pressure increased ≥10 mm Hg; all the cases were successfully managed with topical antiglaucoma medication.ConclusionThe results of this study confirmed previous evidence suggesting that DEX is effective for improving BCVA and CMT in patients with DME.

Early treatment with dexamethasone intravitreal implants in diabetic macular edema: Naïve versus refractory patients.

To assess the efficacy and safety of dexamethasone 0.7 mg implants (DEX-I) in patients with diabetic macular edema (DME) either naïve to therapy or refractory to anti-VEGF treatment, in a single-center, real-world setting. Patients diagnosed with DME and treated with DEX-I were retrospectively enrolled in the study and split in two groups: naïve (Group 1, n = 64) and refractory (Group 2, n = 64) to treatment. Patients were evaluated at baseline, at 1 month, and every 3 months after each DEX-I implant. Main outcome measures were change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to follow-up visits. Significant improvements in BCVA were observed in treatment-naïve patients at 6 months following the first and second DEX-I injection (p = 0.0023 and p = 0.0063, respectively), with significant reductions in mean CMT at 6 months after all DEX implants. In treatment-refractory patients, mean CMT was significantly reduced from baseline to 6 months (p < 0.05) after all DEX-I injections, although no changes were observed in BCVA. DEX-I improved visual acuity and macular edema mostly in treatment-naïve patients, suggesting DEX-I may be a viable first-line treatment option in DME.

Intravitreal Therapy for Diabetic Macular Edema: An Update.

Diabetic macular edema (DME) represents a prevalent and disabling eye condition. Despite that DME represents a sight-threatening condition, it is also among the most accessible to treatment. Many different treatment options including photocoagulation, intravitreal medical treatment (either vascular endothelial growth factor inhibitors or corticosteroids therapies), and surgical removal are currently available. Although laser has been considered as the gold standard for many years, over the past several years vascular endothelial growth factor inhibitors (anti-VEGFs) have become first-line therapy. However, many patients do not adequately respond to them. With the development of sustained-release corticosteroid devices, steroids have gained a presence in the management of the DME. We review and update the role of anti-VEGF and intravitreal sustained-release corticosteroid management of DME. According to the currently available scientific evidence, the choice of one anti-VEGF over another critically depends on the baseline best-corrected visual acuity (BCVA). While aflibercept may be the drug of choice in low baseline BCVA, the three anti-VEGFs (bevacizumab, ranibizumab, and aflibercept) provided similar functional outcomes when the baseline BCVA was higher. DEX implants are a valuable option for treating DME, although they are usually seen as a second choice, particularly in those eyes that have an insufficient response to anti-VEGF. The new evidence suggested that, in eyes that did not adequately respond to anti-VEGF, switching to a DEX implant at the time to 3 monthly anti-VEGF injections provided better functional outcomes.

Intravitreal dexamethasone implant in naïve and previously treated patients with diabetic macular edema: a retrospective study.

To assess the effect of the intravitreal dexamethasone implant (DEX) Ozurdex on the best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with diabetic macular edema (DME). Totally 43 eyes (24 naïve and 19 previously treated) were included in the study. Retrospective and single-center study involved patients with a clinical diagnosed of DME, who received treatment with DEX implant and had a follow-up of at least 12mo. Primary endpoints included changes in BCVA and CRT. At month 12, mean improvement in BCVA from baseline was 20.4±20.8 letters and 6.8±6.9 letters in naïve and previously treated patients, respectively (P=0.0132). The naïve patients achieved the BCVA improvement significantly faster (2.4±1.5mo) than the previously treated ones (3.5±2.4mo, P=0.0298; Mann-Whitney test). The proportion of eyes gaining ≥15 letters was 54.2% and 21.1% in the non-previously treated and previously treated groups, respectively (P=0.0293). CRT was significantly reduced from 484.0±119.8 and 487.5±159.9 µm to 272.0±39.2 and 233.5±65.7 µm in the naïve and previously treated patients, respectively; P<0.0001 each, respectively. The presence of subretinal fluid was significantly associated with the proportion of patients achieving a BCVA improvement ≥5 letters [HR (95%CI), 1.23 (1.04 to 1.45), P=0.0145]; ≥10 letters [HR (95%CI), 1.75 (1.10 to 2.77), P=0.0182]; and ≥15 letters [HR (95% CI), 2.04 (1.03 to 4.02), P=0.0407]. Naïve patients received less DEX implants throughout the study than the previously treated ones (1.8±0.6 vs 2.3±0.6, P=0.0172, respectively). Totally 9 patients (20.9%) have developed ocular hypertension, which was successfully controlled with topical hypotensive drugs. Of the 23 phakic eyes at baseline, 5 eyes (21.7%) either had new onset lens opacity or progression of an existing opacity during the study follow-up. Four of them (2 in the naïve group and 2 in the previously treated one) required cataract surgery at months 4, 6, 6, and 6, respectively. The results obtained in this study may support the early use of DEX Ozurdex as first line therapy in naïve patients.

Journal Review

Journal Review

Can the dexamethasone intravitreal implant Ozurdex be safely administered in an out-of-operating room setting?

Purpose To describe a standardized protocol of the dexamethasone intravitreal (DEX) implant Ozurdex (Allergan, Dublin, Ireland) performed in a controlled environment surgical cabin (CESC). Methods Retrospective and observational study conducted on patients who underwent a DEX implant between May 2011 and June 2019, in a third level University Hospital. The controlled environment surgical cabin (ArcSterile, Imex, Valencia, Spain) used in this study was the MB 20 (2 m width, 1.60 m depth, and 2 m height) with an uninterrupted power system (ARSSAI1) to keep the cabin working for 20 min. The cabin was used in the open mode. A standardized protocol of intravitreal injections in controlled environment surgical cabin was designed. Results From May 2011 to February 2015, a total of 454 DEX implants were performed in the operating room, whereas from March 2015 to June 2019, 1054 DEX devices were implanted using the CESC. The mean number of DEX implants/per week was significantly lower in the operating room than in the CESC [2.3 (2.1 to 2.5) versus 3.8 (3.6 to 4.1), mean difference 1.5 (1.2 to 1.8), p < 0.0001]. The incidence of endophthalmitis was similar in the two populations, 0/454 (0.0%; 95% CI 0.0 to 0.81%) and 0/1054 (0.0%; 95% CI 0.0 to 0.35%) in the operating room and in the CESC, respectively. Conclusions The CESC may be a good alternative to the conventional operating room for the administration of the intravitreal DEX implant.

Intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema in patients not previously treated with any intravitreal drug: a prospective 12-month follow-up study

Objective: To evaluate the mid-long-term efficacy and safety of the dexamethasone intravitreal (DEX) implant (Ozurdex1) in naïve patients with diabetic macular edema (DME).Methods: Prospective and single-center study conducted on consecutive patients with a diagnosis of DME, who received a DEX implant and were followed up for at least 12 months. The main outcomes measurements were the mean change in best corrected visual acuity (BCVA) and in foveal thickness (FT) as compared to the baseline values.Results: Of the 84 screened patients 50 were included in the study. The BCVA significantly improved from 52.4 (20.4) letters at baseline to 62.6 (15.6), 61.2 (18.4), 61.6 (18.6), 60.6 (19.0), and 60.6 (18.8) at 2, 4, 6, 12 months and end of follow-up period, respectively (repeated measures ANOVA and the Greenhouse-Geisser correction; p = .0008). At the end of the follow-up period, a gain of BCVA of ≥5, ≥10, and ≥15 letters were observed in 26 (52.0%), 18 (36.0%), and 16 (32.0%) patients, respectively. The mean FT was significantly reduced from 446.0 (139.9) µm at baseline to 327.2 (103.6) at the end of follow-up (repeated measures ANOVA and the Greenhouse-Geisser correction; p = .0008). During the study follow-up, the patients receive a mean of 3.4 (2.9–3.9) implants. Of the 32 phakic eyes at baseline, 17 (53.1%) either developed new lens opacity or progression of an existing opacity.Conclusion: In eyes with DME not previously treated with intravitreal drugs, DEX implants provide meaningful functional and anatomical benefits, and these results are sustained mid–long-term.

Real-world retrospective comparison of 0.19 mg fluocinolone acetonide and 0.7 mg dexamethasone intravitreal implants for the treatment of diabetic macular edema in vitrectomized eyes.

PurposeThe aim of this study was to evaluate the long-term real-world effectiveness of FAc and DEX implants in vitrectomized DME eyes in a real-world setting.MethodsThis was a non-interventional, retrospective, comparative study of 46 vitrectomized eyes in 33 patients with persistent or recurrent DME quantified best-corrected visual acuity (BCVA), central foveal thickness (CFT) and intraocular pressure (IOP) over up to 37 months.ResultsBoth FAc and DEX treatment led to statistically and clinically significant improvements in BCVA and CFT. FAc >10-letter improvement on the Early Treatment Diabetic Retinopathy Study [ETDRS] chart over months 3–24 and a sustained ~200 µm CFT reduction over months 1–24; DEX: >5-letter improvement on the ETDRS chart at months 1 and 3 and >100 µm CFT reduction at month 1. FAc demonstrated sustained, stable and predictable effects on BCVA and CFT over 24 months and also improved BCVA and decreased CFT in a cohort of DME eyes that was refractory to DEX over 6 months.ConclusionThis real-world study demonstrates long-term effectiveness of FAc in vitrectomized DME eyes and sustained effectiveness in DME eyes that did not respond to DEX therapy.

Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO

Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO

Intraocular pressure change after injection of intravitreal dexamethasone (Ozurdex) implant in Korean patients

Background/AimsTo analyse intraocular pressure (IOP) changes over a period of 1 year after intravitreal dexamethasone (DEX, Ozurdex) implant injection and to compare the results with those of previously published studies...

Dexamethasone for unresponsive diabetic macular oedema: optical coherence tomography biomarkers.

To analyse the effects of intravitreal dexamethasone implant (DEX) in patients with diabetic macular oedema (DME) unresponsive to ranibizumab treatment, in relation to the inflammatory optical coherence tomography (OCT) retinal features, subfoveal neuroretinal detachment (SND) and hyperreflective retinal spots (HRS). Patients with DME poorly responsive to three injections of ranibizumab were treated with DEX. Best-corrected visual acuity (BCVA) and central macula thickness (CMT, measured by Spectralis SD-OCT) were assessed at baseline and at 1, 3, and 6months. Overall, 44 eyes were included in the study. In the whole group, mean BCVA (baseline 51.5±8.3 letters) increased significantly at 1month (to 56.9±8.8 letters; Tukey HSD p=0.017) and was 55.5±8.8 letters at 3months (Tukey HSD p=0.128). Central macula thickness (CMT) reduced significantly at 1 and 3months (417±149μm and 469±128μm, respectively, both Tukey HSD p<0.001 versus baseline). Subgroup analysis showed a significant BCVA increase at 1month in eyes with SND+HRS (from 51.2±9.2 to 58.2±9.0, p=0.029), and a trend to BCVA increase in eyes with HRS (from 52.3±6.4 to 56.8±7.9, p=0.080), with a significant CMT decrease in both groups (p<0.001). No changes of either parameter were found in eyes without SND and HRS. Spectral domain OCT is useful in identifying some inflammatory features in DME. Among DME eyes 'poorly responsive' to ranibizumab, those with SND and HRS responded better to DEX implants than those without these features.

Safety and long-term efficacy of repeated dexamethasone intravitreal implants for the treatment of cystoid macular edema secondary to retinal vein occlusion with or without a switch to anti-VEGF agents: a 3-year experience.

To evaluate the safety and efficacy of repeated dexamethasone intravitreal implants (DEX implants) over 3years in eyes with macular edema (ME) secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). We conducted a 3-year, retrospective, multicenter study that included adult patients with ME secondary to BRVO or CRVO treated with first-line DEX implants. Patients were divided into two different subgroups: patients who received DEX implant injections only (group 1) and those who received DEX implants first and then were switched to anti-VEGF agents (group 2). Primary endpoints were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to month 6 and month 36. Secondary endpoints included changes in both BCVA and CRT after each DEX implant and adverse events, particularly cataract extraction and elevated intraocular pressure (IOP). Sixty-six patients with a median [IQR (interquartile ratio)] age of 72 [65.0; 81.1] years were included (40.9% BRVO, 59.1% CRVO), who received a median of 5.0 [min, 1.0; max, 10.0] DEX implants over 3years. Median [IQR] time to retreatment was 4.8 [4.2; 6.0] months. The median [IQR] improvements in BCVA from baseline until months 6 and 36 were respectively + 10.0 [0; + 20.0] letters (P = 0.040) and + 10.0 [- 8.7; + 20.0] letters (P = 0.364) in the whole population. In group 1, the results were similar, whereas in group 2, BCVA significantly increased at M36 compared with baseline (P = 0.003). The median [IQR] CRT reductions from baseline to months 6 and 36 were respectively - 227.5 [- 337.0; - 52.7] μm and - 224.0 [- 405.0; - 83.8] μm (P < 0.001) in the whole population. Results were similar in both groups. The most common adverse events were cataract extraction (70.4%) and elevated IOP (54.5%). No other serious local complications were observed. Treatment was switched to anti-VEGF agents in 16 (24.2%) patients. DEX implants are an effective treatment for BRVO and CRVO-associated ME over 3years. It is a valid treatment even though complications remain frequent. However, functional efficacy seems to decrease with time and repeated injections.

Real-Life Management of Patients with Retinal Vein Occlusion Using I-Macula Web Platform.

Aim Real-life evaluation in the management of patients affected by macular edema secondary to retinal vein occlusion. Material and Methods A retrospective, observational study using the I-Macula Web platform. Results Thirty-five patients (37 eyes; 15 females and 20 male) affected by RVO were analysed. At 12 months, there was a statistically significant improvement of best-corrected visual acuity (p = 0.0235) and central macular thickness (p < 0.0001). The mean change in visual acuity was 8.9 letters. Twenty-seven eyes underwent DEX implant (n = 62; mean: 2.29) only. Of these, 8, 4, 14, and 1 eyes underwent 1, 2, 3, and 4 DEX implants, respectively. The remaining 10 eyes were also injected with ranibizumab (n = 49; mean: 4.9). At 12 months, 12 eyes (32.5%) presented a dry macula, whereas the remaining 25 eyes (67.5%) still had macular edema. Mean interval between the first and second treatment (T1) and between the second and third treatment (T2) were 5.15 and (T2) 3.7 months, respectively. Where only DEX implants were received, T1 and T2 was 5.1 and 4.9 months, respectively. Conclusions This study confirms that DEX implants and/or anti-VEGF drugs improve visual acuity and central macular thickness in patients affected by RVO.

Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France.

PurposeTo evaluate patterns of use and long-term efficacy and safety of dexamethasone intravitreal implant (DEX implant) in the treatment of macular edema secondary to branch or central retinal vein occlusion (BRVO, CRVO) in French clinical practice.MethodsA 24-month, prospective, multicenter, longitudinal, observational study (LOUVRE) conducted at 48 randomly selected sites in metropolitan France enrolled consecutive adult patients with macular edema following retinal vein occlusion (RVO) who were treated with DEX implant at baseline. Re-treatment with DEX implant and use of other RVO treatments was at the physician’s discretion. The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline to month 6. Secondary endpoints included change in BCVA, intraocular pressure (IOP), adverse events, and RVO treatments administered through month 24.ResultsThe analysis population of 375 patients (53.9 % BRVO, 46.1 % CRVO) received a mean of 2.6 DEX implant injections over 2 years; mean time between injections was 6.6 months. Mean (SD) change in BCVA from baseline was 5.1 (19.0) letters at month 6 (p < 0.001) and 4.6 (22.3) letters at month 24 (p < 0.001). During the study, 208 patients (55.5 %) received treatment other than DEX implant for RVO, usually laser or ranibizumab therapy, with first use of other therapy occurring at a mean of 8.7 months. Mean change from baseline BCVA at month 6 was 5.5 letters (p < 0.001, N = 254) in patients who had received only DEX implant and 4.2 letters (p = 0.006, N = 121) in patients who had received additional other RVO treatment during the first 6 months. At month 24, mean change from baseline BCVA was +20.7 letters in patients treated with a single DEX implant only (p < 0.001), +4.9 letters in patients treated with ≥2 DEX implants only (p = 0.029), and +2.3 letters in patients treated with DEX implant and other RVO treatment (p = 0.143). The most common adverse events (incidence) were cataract progression (39.7 %) and increased IOP (34.4 %). No glaucoma incisional surgeries were required.ConclusionsEfficacy and safety of DEX implant in the treatment of RVO-associated macular edema were demonstrated in the French clinical setting. Patients who switched from DEX implant to other RVO treatments did not have improved outcomes.The study is registered at ClinicalTrials.gov with the identifier NCT01618266.

Tolerance of Dexamethasone intravitreal implant in GAO patients according to their initial treatment and repeated intravitreal injections

AbstractPurposeTo evaluate the tolerance of dexamethasone intravitreal implant (DEX implant) in patients with history of open‐angle glaucoma (OAG) or ocular hypertension (OHT) according to their initial treatment and the repetition of intravitreal injections (IVI).MethodsWe performed a retrospective two‐center clinical study which included 100 patients treated by DEX implants, divided into one group with OAG or OHT patients (n = 50 patients), and one control group (n = 50 patients) including patients with no history of OHT or GAO, matched by age and pathology. IOP was measured and hypotensive treatments were gathered in all patients respectively at baseline, one week, and each month during six months.ResultsMean age was 71.77 (SD +/‐ 10.5) years old in GAO/OHT group and 70.4 (SD +/‐ 10.7) years old in control group and mean number IVI was respectively 2.2 (1–7) and 2.8 (1–11). After the first injection, 50% of OAG/OHT patients and 42% of the control group increased their IOP more than 6 mmHg (p = 0.42). There was no difference between the IOP responses of patients initially treated with monotherapy and the control group but there was significantly more high responders (+&gt;15 mmHg) in patients initially treated with bi and triple therapy. The proportion of responders increased when patient had more than one injection (64 and 56% respectively in OAG and control group, p = 0.22) and the number of high responders doubled (16% at the first IVI, 32% of multi‐IVI). An increased of hypotensive therapy was required in 54% of OAG/OHT patients versus 38% in control group (p = 0.1).ConclusionsDEX implant is well tolerated for the patients under monotherapy. In contrast Patient under bi or triple therapy were at risk of ocular hypertension and filtering surgery. Repeated IVI increased the risk of ocular hypertension.