scholarly journals The Application of Structural Retinal Biomarkers to Evaluate the Effect of Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant on Treatment of Diabetic Macular Edema

Diagnostics ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 413
Author(s):  
Ida Ceravolo ◽  
Giovanni William Oliverio ◽  
Angela Alibrandi ◽  
Ahsan Bhatti ◽  
Luigi Trombetta ◽  
...  

Background: The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME). Methods: 156 treatment-naïve patients with DME were divided in two groups: 75 patients received 3 monthly intravitreal injections of ranibizumab 0.5 mg (Lucentis®) (Group 1) and 81 patients received an intravitreal implant of dexamethasone 0.7 mg (Ozurdex®) (Group 2). Patients were evaluated at baseline (V1), at three months post-treatment in Group 1, and at two months post-treatment in Group 2 (V2). Best-corrected visual acuity (BCVA) and swept source-OCT were recorded at each interval. Changes between V1 and V2 were analyzed using the Wilcoxon test and differences between the two groups of treatment were assessed using the Mann–Whitney test. Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS) as predictive factors for final visual acuity improvement. Results: In both groups, BCVA improved (p-value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed. A superiority of dexamethasone over ranibizumab in reducing the SDN height (p-value = 0.03) and HRS (p-value = 0.01) was documented. Conclusions: Ranibizumab and dexamethasone are effective in the treatment of DME, as demonstrated by functional improvement and morphological biomarker change. DME associated with SDN and HRS represents a specific inflammatory pattern for which dexamethasone appears to be more effective.

2021 ◽  
pp. 112067212110248
Author(s):  
Anna V Bux ◽  
Francesca Fortunato ◽  
Antonio Barone ◽  
Vincenzo Russo ◽  
Nicola Delle Noci ◽  
...  

Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.


2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Sadık Görkem Çevik ◽  
Sami Yılmaz ◽  
Mediha Tok Çevik ◽  
Fatma Düriye Akalp ◽  
Remzi Avcı

Purpose. To compare the effectiveness of sustained-release dexamethasone (DEX) intravitreal implant in nonvitrectomized eyes and vitrectomized eyes with diabetic macular edema (DME). Methods. A retrospective review of the medical records of 40 eyes of 30 consecutive patients with diabetic macular edema who underwent intravitreal DEX implant injection. Patients were divided into 2 subgroups: 31 eyes that were nonvitrectomized (group 1) and 9 eyes that had previously undergone standard pars plana vitrectomy (group 2). The main outcome measures were BCVA and foveal thickness (FT). Results. A significant improvement was seen in BCVA in both group 1 and group 2 at the 1st, 2nd, and 6th months after treatment with DEX implant (p<0.05). In group 1, a significant reduction in FT was observed at the 1st, 2nd, and 6th months (p<0.05). In group 2, a significant reduction in FT was seen at the 1st and 2nd months (p<0.05), but the reduction rate at the 6th month after the injection was not statistically significant (p=0.06). Conclusion. DEX implant is effective for the treatment of diabetic macular edema, and the effectiveness of the drug is similar in vitrectomized and nonvitrectomized eyes.


2021 ◽  
Vol 10 (2) ◽  
pp. 50-58
Author(s):  
Beatriz Oliveira Lopes ◽  
Margarida Sena Brizido ◽  
Florence Aerts ◽  
Susana Morais Pina ◽  
Pedro Santana Simoes ◽  
...  

Background: This study aimed to investigate retinal imaging biomarkers, such as disorganization of the retinal inner layers (DRIL) and/or ellipsoid zone (EZ) disruption by spectral domain optical coherence tomography (SD-OCT), and functional outcomes in eyes treated with 0.2 µg/day of a fluocinolone acetonide intravitreal implant (FAc) after an insufficient response to previous treatments. Methods: This was a retrospective comparative study of 18 eyes (15 patients) with persistent and/or recurrent diabetic macular edema (DME) treated with FAc. Eyes were divided according to the number of prior intravitreal treatments: group 1 (n = 8) with less than or equal to 6 injections (early switch) and group 2 (n = 10) with > 6 injections (late switch). Outcomes included percentage of eyes with DRIL and/or EZ disruption at baseline and analysis of the best corrected visual acuity (BCVA) using ETDRS letters, central macular thickness (CMT), DRIL, and EZ disruption at the last observation. Results: Group 2 revealed a significantly higher percentage of DRIL and/or EZ disruption than group 1 (P < 0.05). At the last observation, group 1 revealed a higher percentage of eyes achieving vision stability/improvement, gaining greater than or equal to15 letters, and achieving greater than or equal to 70 letters (P > 0.05 for all comparisons). The mean BCVA gain was 8.8 and 0.7 letters for groups 1 and 2 (P = 0.397). Both groups revealed a significant mean CMT reduction (>20% reduction from the baseline value), without a significant statistical difference between them (P = 0.749). After treatment, most eyes from both groups showed resolution of DRIL and EZ disruption. Conclusions: Patients with DME presenting with a lower percentage of DRIL and/or EZ disruption at baseline had better functional outcomes, supporting the possible benefit of an early switch to FAc after insufficient response to previous treatments. Future randomized studies with a larger patient cohort are warranted to confirm our conclusions. How to cite this article: Lopes BO, Brizido MS, Aerts F, Pina SM, Simoes PS, Miranda MI. Prognostic biomarkers of chronic diabetic macular edema treated with a fluocinolone acetonide intravitreal implant. Med Hypothesis Discov Innov Ophthalmol. 2021 Summer; 10(2): 50-58. https://doi.org/10.51329/mehdiophthal1421


Author(s):  
Ernest V. Boiko ◽  
Dzhambulat H. Oskanov ◽  
Sergei V. Sosnovskii

Background. Diabetic macular edema is a specific complication of diabetes. Antiangiogenic therapy is an effective treatment for diabetic macular edema. Another manifestation of diabetic retinal damage is a change in the vitreoretinal interface. There is evidence of the effectiveness of vitrectomy in the treatment of other ophthalmic diseases with pathology of vitreoretinal interface. Purpose. Comparative analysis of the effectiveness of antiangiogenic therapy and vitrectomy in the treatment of diabetic macular edema occurring against the background of the vitreoretinal interface pathology. Materials and methods. The study involved 60 patients (60 eyes) with diabetic macular edema accompanied by vitreoretinal interface pathology. The patients were divided into 2 groups: group 1 30 eyes, which received antiangiogenic therapy with intravitreal injections of ranibizumab; group 2 30 eyes, on which vitrectomy was performed with removal of the internal limiting membrane. The observation period was 12 months. Results. In group 1, a significant increase in visual acuity was obtained 1 month after the intravitreal injections. During the observation and performing, if necessary, intravitreal injections, visual acuity decreased and by 12 months did not statistically differ from the initial one. In group 2, there was a gradual reliable increase in the visual acuity. A decrease in retinal thickness in the second group was significantly greater by the end of the study. The average number of intravitreal injections required during the observation in the first group was significantly greater than in the second group. Conclusions. In the patients with diabetic macular edema against the background of pathology of the vitreoretinal interface, vitrectomy led to a significant increase in visual acuity by 12 months of observation, in contrast to the patients receiving antiangiogenic therapy only. In the patients with diabetic macular edema and pathology of the vitreoretinal interface, complex treatment (antiangiogenic therapy + vitrectomy) led to a significant decrease in the thickness of the retina and the number of injections of angiogenesis inhibitors.


2020 ◽  
Vol 36 (3) ◽  
Author(s):  
Muhammad Ali Haider ◽  
Uzma Sattar ◽  
Syeda Rushda Zaidi

Purpose: To evaluate the change in visual acuity in relation to decrease in central macular thickness,after a single dose of intravitreal Bevacizumab injection.Study Design: Quasi experimental study.Place and Duration of Study: Punjab Rangers Teaching Hospital, Lahore, from January 2019 to June 2019.Material and Methods: 70 eyes with diabetic macular edema were included in the study. Patients having high refractive errors (spherical equivalent of > ± 7.5D) and visual acuity worse than +1.2 or better than +0.2 on log MAR were excluded. Central macular edema was measured in μm on OCT and visual acuity was documentedusing Log MAR chart. These values were documented before and at 01 month after injection with intravitrealBevacizumab. Wilcoxon Signed rank test was used to evaluate the difference in VA beforeand after the anti-VEGF injection. Difference in visual acuity and macular edema (central) was observed,analyzed and represented in p value. P value was considered statistically significant if it was less than 0.01%.Results: Mean age of patients was 52.61 ± 1.3. Vision improved from 0.90 ± 0.02 to 0.84 ± 0.02 on log MARchart. The change was statistically significant with p value < 0.001. Central macular thickness reduced from 328 ±14 to 283 ± 10.6 μm on OCT after intravitreal anti-VEGF, with significant p value < 0.001.Conclusion: A 45 μm reduction in central macular thickness was associated with 0.1 Log MAR unit improvementin visual acuity after intravitreal Bevacizumab in diabetic macular edema.


2019 ◽  
Vol 10 (4) ◽  
pp. 3000-3005
Author(s):  
Khlood M. Aldossary ◽  
Anfal Alruzuq ◽  
Ghady Almohanna ◽  
Hessa Almusallam ◽  
Sara Alamri ◽  
...  

Diabetic macular edema (DME) is a significant cause of diabetic retinopathy and a major cause of vision loss. In this study, we aimed to evaluate and compare the efficacy of two injectable drugs; intravitreal Aflibercept and intravitreal Ranibizumab for the treatment of DME of the eyes. A retrospective chart review was conducted for patients diagnosed with DME from March 2014 to January 2019 who received either intravitreal Aflibercept or intravitreal Ranibizumab injection. A total of 57 eyes were included, of which 19 eyes were treated with intravitreal Ranibizumab injection, and 38 eyes were treated with intravitreal Aflibercept injection; all eyes were examined for 3 months. Two outcomes were assessed in this study, namely; visual acuity (VA) and central macular thickness (CMT). The mean age in the Ranibizumab group was 61.1±9.5 vs 64.3±10.2 in the Aflibercept group with no significant difference (p-value=0.25). The ratio of improvement in visual acuity (VA) in the Ranibizumab group was 68.4% vs 44.7% in the Aflibercept group; (p-value=0.038) which demonstrates the superiority of Ranibizumab over Aflibercept concerning visual acuity result. However, there is no statistically significant difference between the ratio of improvement in central macular thickness (CMT) results in both groups; (p-value=1.00). In fact, the ratio of improvement in CMT in both groups was the same 78.9% for both the groups. The pre and post results demonstrated improvement in post-procedural for CMT among both the groups but only Ranibizumab group showed VA improvement post-procedural. Through this study, we concluded that both injectable drugs improve visual acuity (VA) and decrease central macular thickness (CMT) in eyes with DME. However, Ranibizumab is superior in improving visual acuity compared to Aflibercept. Further comparative effectiveness trials between Aflibercept and Ranibizumab are still warranted.


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.


2017 ◽  
Vol 28 (1) ◽  
pp. 74-79 ◽  
Author(s):  
Giuseppe Lo Giudice ◽  
Antonio Avarello ◽  
Gianluca Campana ◽  
Alessandro Galan

Purpose: To evaluate the early effects of dexamethasone (DEX) intravitreal implants in patients with diabetic macular edema (DME). Methods: This was a prospective, single-arm, interventional clinical series. Eighteen patients (18 eyes) with chronic/recalcitrant or naive DME were included. Patients underwent single DEX intravitreal implant. Clinical assessments, including ophthalmologic examination, central retinal thickness (CRT) measurement by spectral-domain optical coherence tomography (SD-OCT) scan, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were carried out at baseline, 1-3 hours, and then 3, 7, and 30 days after treatment. The main outcome was change in CRT on SD-OCT, while secondary outcome measures included visual acuity (VA) and changes in IOP following implant. Results: Mean CRT significantly decreased from 565 ± 171 µm at baseline to 310 ± 89 µm at end of follow-up (p<0.001), with reduction becoming evident 1-3 hours after injection. Mean BCVA also significantly improved 7 days and 30 days after treatment up to 0.14 logMAR (p<0.05). All patients had a controlled IOP after the injection with only 1/18 eyes having a transient increase in IOP during follow-up. Conclusions: This is the first study showing very early effects of DEX implants on CRT reduction and VA improvement in DME.


2021 ◽  
Author(s):  
Sahba Fekri ◽  
Masoud Soheilian ◽  
Sepehr Roozdar ◽  
Seyed-Hossein Abtahi ◽  
Hosein Nouri

Abstract Purpose: Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.Methods: 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1 ), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration+ oral vitamin D supplementation (Group 3). Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after the triple IVB injections were completed. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration. Results: In months 1, 3, and 6, after the basic triple IVB injection, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 (sufficient vitamin D and corrected hypovitaminosis D) in month 6 were more significant than in group 2 (uncorrected hypovitaminosis D) (p <0.001). The mean number of IVB injections during follow-up was 5.33 (range: 4-7), which did not differ between the groups.Conclusion: Correction of vitamin D deficiency in DME patients with type 2 diabetes and vitamin D deficiency, in addition to IVB injections, may play a role in improving CDVA and CMT. However, this beneficial effect seems to be delayed by several months.Trial registration: Iranian Registry of Clinical Trials (IRCT), IRCT20200407046978N1, registered on April 11, 2020, - retrospectively registered. https://en.irct.ir/trial/46999


Author(s):  
Amr Abdelrahman ◽  
Wagiha Massoud ◽  
Ahmed Mohamed Kamal Elshafei ◽  
Mahmoud Genidy ◽  
Raafat Mohyeldeen Abdelrahman Abdallah

Abstract Background To compare the therapeutic effects of subthreshold micropulse laser (SML) versus intravitreal injection of ranibizumab in treatment of diabetic macular edema (DME) both anatomically using optical coherence tomography (OCT) and functionally using best corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG). Methods his study was an interventional prospective randomized comparative study. The study included 120 eyes classified into 3 groups: Group 1 included 40 eyes of 28 patients treated by SML laser, group 2 included 40 eyes of 32 patients treated by intravitreal injection of ranibizumab, and group 3 (control group for mfERG) included 40 eyes of 20 patients with diabetes mellitus (DM) of more than 10 year duration with no signs of diabetic retinopathy (DR). BCVA measurements, OCT and mfERG were done for the cases before and after interference and were followed up for 6 months Results By the end of the follow up period, BCVA significantly improved by 31% in group 1 vs 93% in group 2 with a statistically highly significant difference between the two groups (p value < 0.001). There was also a significant decrease in central subfield thickness in both groups with more reduction in group 2 compared with group 1 (p value < 0.001). There was a significant improvement in P1 amplitude of mf-ERG in group 2 (p value < 0.002) with no significant improvement in group 1. There was a significant decrease in P1 implicit time in group 2 (p value < 0.001) while there was no significant decrease in group1. Conclusions Intravitreal injection of ranibizumab is a superior treatment modality for DME compared with SML regarding both anatomical and functional outcomes. Trial registration: This study has been approved by the local ethical committee of faculty of medicine of Minia University and retrospectively registered at the clinical trial gov. with Identifier: NCT04332133.


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