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

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.

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Efficacy of Intravitreal Dexamethasone Implant in Different Patterns of Diabetic Macular Edema

Journal of Ophthalmic and Vision Research ◽

10.18502/jovr.v15i4.7787 ◽

2020 ◽

Author(s):

Claudio Furino ◽

Alfredo Niro ◽

Michele Reibaldi ◽

Maria Oliva Grassi ◽

Francesco Boscia ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Serous Retinal Detachment ◽

Intravitreal Dexamethasone Implant ◽

The Mean ◽

Group 2 ◽

Intravitreal Dexamethasone ◽

Pattern Group ◽

Group 1

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.

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Comparison of aflibercept and ranibizumab in diabetic macular edema associated with subretinal detachment

European Journal of Ophthalmology ◽

10.1177/1120672119827855 ◽

2019 ◽

Vol 30 (2) ◽

pp. 363-369 ◽

Cited By ~ 1

Author(s):

Abdullah Ozkaya ◽

Gokhan Demir ◽

Asli Kirmaci

Keyword(s):

Visual Acuity ◽

Retinal Detachment ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Secondary Outcome ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

Intravitreal Aflibercept ◽

Best Corrected Visual Acuity

Purpose: To compare the efficacy of ranibizumab and aflibercept in the treatment of diabetic macular edema associated with subfoveal retinal detachment. Methods: This is a retrospective, comparative study. The treatment-naïve diabetic macular edema patients who had diabetic macular edema associated with subfoveal retinal detachment and underwent intravitreal aflibercept or intravitreal ranibizumab treatment were included. The patients were treated on a pro re nata treatment regimen after a loading dose of 3-monthly injections and the follow-up time was 12 months. The primary outcome measure of this study was the presence of subfoveal retinal detachment after treatment at different time points. The secondary outcome measures were the change in best corrected visual acuity and central retinal thickness. Results: A total of 46 eyes of 46 patients were included. The aflibercept group consisted of 20 and the ranibizumab group consisted of 26 eyes. During the follow-up period of 12 months, subfoveal retinal detachment was completely resolved in 75% versus 57.7% of the eyes at month 3 (p = 0.2), 90% versus 76.9% at month 6 (p = 0.2), 90% versus 65.4% at month 9 (p = 0.05), and 100% versus 80.8% at month 12 (p = 0.03) in the intravitreal aflibercept versus intravitreal ranibizumab groups. The change in best corrected visual acuity was not statistically different between the groups at months 3, 6, 9, and 12, respectively (p > 0.05 for all). Conclusion: Both intravitreal aflibercept and intravitreal ranibizumab were effective in regards to anatomical and functional outcomes of diabetic macular edema patients associated with subfoveal retinal detachment. Interestingly, intravitreal aflibercept seemed more effective than intravitreal ranibizumab in the resolution of subfoveal retinal detachment at month 12.

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Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial

Ophthalmic Research ◽

10.1159/000512469 ◽

2020 ◽

Vol 64 (3) ◽

pp. 398-404

Author(s):

Jia Li ◽

Xu Bai ◽

Xiaoyue Guan ◽

Hongfeng Yuan ◽

Xiang Xu

Keyword(s):

Visual Acuity ◽

Adverse Events ◽

Phase 1 ◽

Optic Canal ◽

Traumatic Optic Neuropathy ◽

Corrected Visual Acuity ◽

Group 2 ◽

Best Corrected Visual Acuity ◽

Group 1

Purpose: This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). Methods: This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. Results: All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (p > 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (p < 0.05); however, there were no statistically significant differences between the groups (p > 0.05). In addition, no adverse events related to local transplantation were observed in the patients. Conclusions: A single, local MSC transplantation in the optic nerve is safe for patients with TON.

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Visual/anatomical outcome of diabetic macular edema patients lost to follow-up for more than 1 year

Scientific Reports ◽

10.1038/s41598-021-97644-2 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Ji Soo Kim ◽

Seungheon Lee ◽

Jin Young Kim ◽

Eoi Jong Seo ◽

Ju Byung Chae ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Poor Response ◽

Control Group ◽

Anti Vegf ◽

Treatment Naïve ◽

Lost To Follow Up ◽

Anatomical Outcome

AbstractTo investigate the visual/anatomical outcome of diabetic macular edema (DME) patients lost to follow-up (LTFU) for more than 1 year during intravitreal anti-VEGF treatment. A retrospective review of 182 treatment-naïve DME patients was performed. Among them, we identified patients LTFU for more than 1 year during anti-VEGF treatment. Visual acuity and anatomic outcomes at the first visit, last visit before being LTFU, return visit, and after re-treatment were analyzed and compared with those of DME patients with regular follow-up. Patients who had continuous follow-up visits were assigned to the control group. Sixty patients (33%) with DME were LTFU for more than 1 year during anti-VEGF treatment. Multivariate analysis revealed that the ratio of male (p = 0.004), diabetes mellitus (DM) duration less than 5 years (p = 0.015), and poor early anatomic response (p = 0.012) were higher compared to the control group. Eighteen patients returned to the clinic and received re-treatment. After re-treatment with anti-VEGF, central subfield thickness (CST) was significantly improved to the CST of before LTFU. However, visual acuity did not recover to the level before LTFU (0.63 ± 0.26 vs. 0.45 ± 0.28, p = 0.003). About thirty percent of DME patients were LTFU for more than 1 year. Permanent visual loss was observed in these LTFU patients. Patients with a high risk of LTFU such as male, early DM, and poor response after initial injections should be treated more aggressively to improve the visual outcomes.

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Comparison of Perioperative Ranibizumab Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery

Journal of Ophthalmology ◽

10.1155/2016/7945619 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Erhan Yumuşak ◽

Kemal Örnek

Keyword(s):

Visual Acuity ◽

Cataract Surgery ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Intravitreal Ranibizumab ◽

Foveal Thickness ◽

Group 3 ◽

Group 2 ◽

Baseline Visual Acuity

Purpose. To compare the efficacy of perioperative ranibizumab injections on diabetic macular edema (DME) in patients undergoing cataract surgery.Methods. This study included 59 eyes of 59 patients. All patients had advanced cataract with DME and underwent an uneventful phacoemulsification surgery. There were 3 subgroups. The first group received intravitreal ranibizumab injection 2 weeks preoperatively, the second group received intraoperatively, and the third group received 2 weeks postoperatively. Follow-up examinations were performed at 1 week as well as at 1 and 3 months.Results. Baseline visual acuity showed a significant increase in all groups at 1 month. In group 1, compared to baseline value, foveal thickness (FT) increased significantly at 1 month and showed a significant decrease up to month 3. In group 2, FT increased at month 1 and this continued up to month 3. In group 3, FT increased at month 1 and was almost stable up to month 3. There were not any significant differences for visual acuity and FT between the groups.Conclusions. Although intrapostoperative ranibizumab injection for DME seems to be more effective than preoperative injections in patients undergoing cataract surgery, the treatment still needs to be continued following surgery.

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

Diagnostics ◽

10.3390/diagnostics10060413 ◽

2020 ◽

Vol 10 (6) ◽

pp. 413

Author(s):

Ida Ceravolo ◽

Giovanni William Oliverio ◽

Angela Alibrandi ◽

Ahsan Bhatti ◽

Luigi Trombetta ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Post Treatment ◽

Wilcoxon Test ◽

P Value ◽

Swept Source ◽

Intravitreal Implant ◽

Group 2 ◽

Group 1

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.

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Adjunct Intravitreous Triamcinolone Acetonide in the Treatment of Diabetic Macular Edema with Anti-VEGF Agents

Journal of Ophthalmology ◽

10.1155/2016/5282470 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Robert B. Garoon ◽

Robert E. Coffee ◽

Lai Jiang ◽

Christina Y. Weng ◽

Petros E. Carvounis

Keyword(s):

Macular Edema ◽

Triamcinolone Acetonide ◽

Diabetic Macular Edema ◽

Anti Vegf ◽

Treatment Naïve ◽

The Mean ◽

Group 2 ◽

Endothelial Growth Factor ◽

Phakic Eyes ◽

Group 1

Aims.To compare visual and anatomic outcomes of adjunct intravitreous (IVT) triamcinolone acetonide to antivascular endothelial growth factor (VEGF) injections to IVT anti-VEGF injections alone for center-involving diabetic macular edema (DME) in treatment-naïve eyes.Methods.Retrospective study of treatment-naïve eyes with center-involving DME. The primary outcome was the change in best corrected visual acuity (BCVA) in eyes receiving only IVT anti-VEGF (group 1) and eyes receiving IVT anti-VEGF and adjunct IVT-TA (group 2).Results.Included were 192 eyes. The mean change in BCVA was +3.5 letters in group 1 compared to −3.5 letters in group 2 (p=0.048). Final macular thickness improved by −94 μm in group 1 versus −68 μm in group 2 (p=0.26). In group 1, 5/150 eyes compared to 9/42 eyes in group 2 (3.3% versus 21%,p=0.0005) had a IOP >10 mmHg increase. Six of 126 phakic eyes in group 1 versus 12/33 phakic eyes in group 2 underwent cataract surgery (4.7% versus 36.3%,p=0.00009).Conclusions.IVT-TA results in no additional benefit in eyes treated with anti-VEGF agents for DME.

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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

HERALD of North-Western State Medical University named after I I Mechnikov ◽

10.17816/mechnikov47394 ◽

2021 ◽

Vol 12 (4) ◽

pp. 55-60

Author(s):

Ernest V. Boiko ◽

Dzhambulat H. Oskanov ◽

Sergei V. Sosnovskii

Keyword(s):

Visual Acuity ◽

Comparative Analysis ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Antiangiogenic Therapy ◽

Angiogenesis Inhibitors ◽

Intravitreal Injections ◽

Vitreoretinal Interface ◽

Group 2 ◽

Group 1

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.

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Interdigitation and ellipsoid zones disruption correlate with visual outcomes among treatment naive patients with diabetic macular edema

Ophthalmic Research ◽

10.1159/000513204 ◽

2020 ◽

Author(s):

Nardine Sharef ◽

Rabea Kassem ◽

Idan Hecht ◽

Asaf Bar ◽

Idit Maharshak ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Automatic Measurement ◽

Defect Size ◽

Anti Vegf ◽

Snellen Visual Acuity ◽

Treatment Naïve ◽

The Mean

Introduction: We have recently shown that defects in interdigitation and ellipsoid zones (IZ and EZ) can predict response to anti-VEGF therapy in a small group of treatment-naïve diabetic macular edema (DME) patients. The aim of the current study is to further evaluate this association in a larger study group of patients over a longer follow-up time. Methods: Thirty eyes of 30 treatment-naïve DME patients were analyzed in this retrospective study. The integrity of foveal IZ and EZ was evaluated using OCT at the diagnosis of DME and following anti-VEGF injections. The defect size was correlated with best-corrected visual acuity (BCVA) and central macular thickness (CMT). Results: The mean patients' age at baseline was 63.0±10.0 years. Patients underwent 3.9±2.9 anti-VEGF injections for a mean of 9.1±4.8 months. Following treatment, the mean Snellen visual acuity improved from 20/52 to 20/44 (p=0.05), CMT decreased from 432.5±141.4 m to 375.2±121.4 µm (p=0.05) and IZ/EZ defect size decreased from 259.83±375.94 µm to 65.34±143.97 µm (p=0.001). In patients with no IZ/EZ defects at baseline the mean Snellen visual acuity was better when compared to those with IZ/EZ defects (20/36 vs. 20/70, p=0.031). The number of eyes with IZ/EZ defects decreased from 17 (57%) at baseline to 6 (20%) at end of follow-up (p<0.01). BCVA gain correlated with IZ/EZ defect size reduction (r=0.41, p=0.02) but not with improvement in CMT (r=0.28, p=0.121). Conclusions: IZ/EZ defect size correlated not only with baseline BCVA, but also predicted the change in BCVA after anti-VEGF treatment. Possible future automatic measurement of IZ/EZ defect size might prove helpful for evaluation of treatment response.

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Comparison of the Effectiveness of Intravitreal Ranibizumab for Diabetic Macular Edema in Vitrectomized and Nonvitrectomized Eyes

Ophthalmologica ◽

10.1159/000446992 ◽

2016 ◽

Vol 236 (2) ◽

pp. 67-73 ◽

Cited By ~ 5

Author(s):

Yoshito Koyanagi ◽

Shigeo Yoshida ◽

Yoshiyuki Kobayashi ◽

Yuki Kubo ◽

Muneo Yamaguchi ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Treatment Option ◽

Central Macular Thickness ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

The Mean ◽

The Difference ◽

Best Corrected Visual Acuity

Purpose: To compare the effectiveness of intravitreal ranibizumab (IVR) for diabetic macular edema (DME) between eyes with and without previous vitrectomy. Procedures: We prospectively assessed the best-corrected visual acuity (BCVA) and central macular thickness (CMT) after IVR for 6 months. Results: There were no significant differences in the baseline BCVA and CMT between both groups. In the nonvitrectomized group (n = 15), the mean changes of BCVA and CMT from baseline to month 6 were significant (p < 0.01). In the vitrectomized group (n = 10), the improvement appeared to be slower, and the mean BCVA improvement was not significant (p = 0.5), although the mean CMT decrease was significant (p < 0.05). There were no significant differences in the mean changes of BCVA and CMT between both groups at 6 months. Conclusions: The difference in the effectiveness of IVR between both groups was not significant. IVR can be a treatment option even for vitrectomized DME eyes.

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