scholarly journals Efficacy and Safety of a Dexamethasone Implant in Patients with Diabetic Macular Edema at Tertiary Centers in Korea

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Byung Gil Moon ◽  
Joo Yong Lee ◽  
Hyeong Gon Yu ◽  
Ji Hun Song ◽  
Young-Hoon Park ◽  
...  

Purpose. To evaluate the real-world efficacy and safety of the dexamethasone implant (DEX implant) in patients with diabetic macular edema (DME). Methods. Retrospective, multicenter, and noncomparative study of DME patients who were treated with at least one DEX implant. A total of 186 eyes from 165 patients were included. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and number of retreatments were collected. Data at baseline and monthly for 6 months were analyzed. Results. The average baseline BCVA and CRT were 0.60 LogMAR and 491.6 μm, respectively. The mean BCVA improved until 3 months and then decreased up to 6 months of follow-up (0.53, 0.49, and 0.55 LogMAR at 1, 3, and 6 months; p=0.001, <0.001, and 0.044, resp.). The change of mean CRT was similar to BCVA (345.0, 357.7, and 412.5 μm at 1, 3, and 6 months, p<0.001, <0.001, and <0.001, resp.). 91 eyes (48.9%) received additional treatment with anti-VEGF or DEX implant. The average treatment-free interval was 4.4 months. In group analyses, the DEX implant was more effective in pseudophakic eyes, DME with subretinal fluid (SRF), or diffuse type. Conclusions. Intravitreal dexamethasone implants are an effective treatment for patients with DME, most notably in pseudophakic eyes, DME with SRF, or diffuse type. A half of these patients require additional treatment within 6 months.

2020 ◽  
pp. 112067212094976
Author(s):  
Dhanashree Ratra ◽  
Unnati Sharma ◽  
Daleena Dalan

Purpose: To evaluate the efficacy and safety of intravitreal dexamethasone implant in treatment naïve eyes with diabetic macular edema (DME). Methods: A retrospective analysis of treatment naïve eyes with DME which received intravitreal dexamethasone implant between January 2016 and March 2018 was done. Demographic details of the patients, ocular examination findings at baseline and on follow up visits were noted. Morphological features of DME and central macular thickness were noted on optical coherence tomography at each visit. The details regarding additional treatment for macular edema on follow up were noted. Results: Sixty five eyes were included in the study. The mean age was 59.14 ± 9.59 years. The follow up ranged from 6 to 48 months. Psuedophakic eyes showed visual improvement whereas the phakic eyes showed stable vision. The central foveal thickness showed significant reduction ( p = 0.05) in all the eyes. The best corrected visual acuity at final follow up (+0.65 logMAR) was slightly less as compared to baseline (+0.62 logMAR). Retreatment was needed in 37% eyes and antiglaucoma medications in 8% eyes. Cataract progression was noted in 24 eyes (37%); 17 eyes (26.1%) underwent surgery. Notably, 27 eyes (41.5%) had some degree of macular ischemia at baseline. And five eyes (7.7%) showed progression of retinopathy leading to vitreous hemorrhage. Conclusion: Dexamethasone implant is helpful in reducing the macular thickness and stabilizing the vision in treatment naïve DME; requiring less number of treatment sessions. However, it does not prevent progression of diabetic retinopathy. The visual improvement may be affected by cataract and macular ischemia.


2020 ◽  
Vol 17 ◽  
Author(s):  
Sanjay Kumar Mishra ◽  
Shruti Sinha ◽  
Ravi Chauhan ◽  
Ashok Kumar

Introduction: In the working age population, Diabetic Macular Edema (DME) is the most common cause of visual loss. Purpose: The present study is aimed to assess the safety and efficacy of intravitreal injection of Ranibizumab (IVR) versus intravitreal Dexamethasone implant (IVD) in patients with DME in a tertiary care centre over 4 months. Methods: This is a comparative, prospective, randomized study that was done on 140 patients with macular edema confirmed on optical coherence tomography (OCT). IVD group received Ozurdex® (Allergan, Inc, Ireland) while the IVR group received Lucentis® (Novartis, Basel, Switzerland) followed up at day-1 and weeks 4, 8, 12,16. Patients were divided into Group A: patients were given 3 doses (monthly) of IVR 0.3 mg in 0.05 ml (n=70). Group B: patients given a single dose of IVD implant 0.7 mg (n=70). Results: The mean number of injections given was 1 Ozurdex® per patient Vs 3 Lucentis® per patient. The maximum reduction in central macular thickness (CMT) with IVD was 167.8 µm and 138.8µm in the 2nd and 3rd months, respectively with IVR. The Mean best-corrected visual acuity (BCVA) in the 4th month was 0.34 logMAR and 0.33 logMAR, in IVD and IVR group, respectively with consistent improvement. Patients with 0-5 letters, 6-10 letters and 10-15 letters, and >15 letters visibility in IVD group were 9.5, 20.6, 4.8, 6.4 %, and 20.4, 18.8, 20.3 20.3 % in IVR groups, respectively. The maximum intraocular pressure (IOP) rise with IVD was found to be 16 mmHg in 2 patients (3.17 %). The patients with IOP rise >10 mmHg was observed in 14/63 patients (22.22 %), the majority of patients indicated a high rise at 2nd month and all returning to baseline by 4th month. No reports of infectious endophthalmitis or new cataracts were detected in either treated groups. Conclusion: Both intravitreal Ranibizumab injection and Dexamethasone implants were found to be safe and effective in lowering CMT and improving BCVA at the 4-month follow up in patients with DME. Since there was no recurrence in CMT in the Dexamethasone implant group, we suggest that early administration before the 4th month may indicate superior efficacy over the ranibizumab injection. Further randomized trials in a large sample size with a longer period follow-up would be performed to justify the obtained results in the present study.


Author(s):  
Claudio Furino ◽  
Alfredo Niro ◽  
Michele Reibaldi ◽  
Maria Oliva Grassi ◽  
Francesco Boscia ◽  
...  

Purpose: Different patterns of diabetic macular edema (DME) suggest different pathogenesis and drug response. We evaluated the outcomes after intravitreal dexamethasone (DEX) implant for DME with or without serous retinal detachment (SRD). Methods: In this retrospective study, 22 naïve patients (23 eyes) with DME who underwent a single DEX implant were evaluated. Based on the optical coherence tomographic pattern of DME, 12 eyes had a cystoid macular edema pattern (Group 1) and 11 eyes had an SRD pattern (Group 2). The best-corrected visual acuity (BCVA), central retinal thickness (СRТ), central retinal volume (CRV), SRD height (SRDh), and intraocular pressure (IOP) were recorded before and at two and four months after the treatment. Results: There were no significant differences between the groups regarding demographic, clinical data and outcomes at baseline. In Group 1, the CRT and CRV significantly decreased at two months (P = 0.002 and P = 0.01, respectively), while the BCVA significantly improved at four months (P = 0.03). In Group 2, the CRT and CRV significantly improved (P < 0.01 and P ≤ 0.01, respectively) during the follow-up period. At four months, both groups showed a recurrence of DME, Group 1 in particular (two-month CRT reduction, –149 ± 127 μm vs four-month CRT reduction, –72 ± 174 μm; P = 0.04). The mean reduction in CRV was significantly different at four months (Group 1, –0.49 ± 1.7 mm3 vs Group 2, –1.3 ± 1.3 mm3; P = 0.04). In Group 2, the SRDh significantly decreased at two (P = 0.01) and four months (P = 0.01). Four cases with elevated IOP were managed. Conclusion: DEX implants were found to be effective in different patterns of DME. The SRD pattern may predict a longer-lasting morphologic efficacy.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Eduardo A. Novais ◽  
Mauricio Maia ◽  
Paulo Augusto de Arruda Mello Filho ◽  
João Rafael de Oliveira Dias ◽  
José Maurício B. B. Garcia ◽  
...  

Purpose. To evaluate the best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of dexamethasone implants needed to treat cystoid macular edema (CME) from various etiologies over 12 months in vitrectomized and nonvitrectomized eyes.Methods. This multicenter retrospective cohort study included 112 patients with CME secondary to retinal diseases treated pro re nata (PRN) with a 0.7 mg intravitreal dexamethasone implant for 12 months. The BCVA, CRT, adverse events, safety data, and number of implants were recorded.Results. Vitrectomized and nonvitrectomized eyes received means of three implants and one implant, respectively, over 12 months (P<0.001). The mean BCVA of all patients improved from 0.13 at baseline to 0.33 (P<0.001) 12 months after one (P=0.001), two (P=0.041), and three (P<0.001) implants but not four implants (P=0.068). The mean baseline CRT decreased significantly (P<0.001) from 463 to 254 microns after 12 months with one (P<0.001), two (P=0.002), and three (P=0.001) implants but not with four implants (P=0.114). The anatomic and functional outcomes were not significantly different between vitrectomized and nonvitrectomized eyes. Increased IOP was the most common adverse event (23.2%).Conclusions. Dexamethasone implant administered PRN improved VA and decreased CRT in CME, with possible long-term clinically relevant benefits for treating CME from various etiologies. Vitrectomized eyes needed more implants compared with nonvitrectomized eyes.


2016 ◽  
Vol 26 (5) ◽  
pp. 454-459 ◽  
Author(s):  
Frederic Matonti ◽  
Stephan Pommier ◽  
Franck Meyer ◽  
Christian Hajjar ◽  
Pierre Yves Merite ◽  
...  

2015 ◽  
Vol 233 (3-4) ◽  
pp. 169-175 ◽  
Author(s):  
Sebastien Guigou ◽  
Stephan Pommier ◽  
Franck Meyer ◽  
Christian Hajjar ◽  
Pierre Yves Merite ◽  
...  

Purpose: To evaluate the efficacy and safety of intravitreal implant of dexamethasone (Ozurdex®) in diabetic macular edema (DME). Methods: This was a retrospective multicenter noncomparative study. Seventy-eight patients with DME followed for at least 6 months were included (P1.5 Network). Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP) and cataract progression were studied at baseline and then at 1, 2, 4 and 6 months. Results: The mean CRT decrease from baseline was 145.2 µm at 6 months. The mean BCVA improvement from baseline was 6.7 at 6 months. An increase in IOP was observed for 11.7% of patients, and all patients were managed by topical treatment. No glaucoma or cataract surgery was necessary, and no endophthalmitis was reported. Conclusions: One injection of Ozurdex has an anatomical and functional effectiveness for the treatment of DME. Side effects were rare and manageable in our practice.


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