Short-Term Outcomes of Refractory Diabetic Macular Edema Switch From Ranibizumab to Dexamethasone Implant and the Influential Factors: A Retrospective Real World Experience

Introduction: To evaluate the effectiveness and safety of intravitreal dexamethasone (DEX) implants in refractory diabetic macular edema (DME) treated by intravitreal ranibizumab.Materials and Methods: We retrospectively analyzed DME patients who received DEX implant treatment after being refractory to at least 3 monthly intravitreal ranibizumab injections. The main outcomes were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and intraocular pressure (IOP).Results: Twenty-nine eyes of 26 patients who had previously received an average of 8.1 ± 4.4 ranibizumab injections were included. Patients received between one and three DEX implants during 12.4 ± 7.4 months of follow-up. The mean final CRT significantly decreased from 384.4 ± 114.4 μm at baseline to 323.9 ± 77.7 μm (p = 0.0249). The mean final BCVA was 51.4 ± 21.3 letters, which was not significant compared to baseline (44.9 ± 30.2 letters, p = 0.1149). Mean IOP did not increase significantly. All patients tolerated the treatment well without serious adverse events. Higher baseline CRT and worse BCVA correlated with better therapeutic responses.Conclusion: Switching to DEX implant is feasible and safe for treating patients of DME refractory to intravitreal ranibizumab in real world. Further larger-scale or multicenter studies would be conducted to explore different DEX treatment strategies for DME, such as first-line or early switch therapy, for better BCVA improvement.

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Short-term Outcomes of Refractory Diabetic Macular Edema Switch from Ranibizumab to Dexamethasone Implant and the Influential Factors: A Retrospective Real World Experience.

10.21203/rs.3.rs-104770/v1 ◽

2020 ◽

Author(s):

Ning-Yi Hsia ◽

Chun-Ju Lin ◽

Huan-Sheng Chen ◽

Cheng-Hsien Chang ◽

Henry Bair ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Real World ◽

Influential Factors ◽

Intravitreal Ranibizumab ◽

Serious Adverse Events ◽

Refractory Diabetic Macular Edema ◽

The Mean ◽

Intravitreal Dexamethasone

Abstract Background: To evaluate the effectiveness and safety of intravitreal dexamethasone (DEX) implants in refractory diabetic macular edema (DME) treated by intravitreal ranibizumab.Methods: We retrospectively analyzed DME patients who received DEX implant treatment after being unresponsive to at least three monthly intravitreal ranibizumab injections. The main outcomes were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and intraocular pressure (IOP).Results: Twenty-nine eyes of 26 patients who had previously received an average of 8.1 ± 4.4 ranibizumab injections were included. Patients received between one and three DEX implants during 12.4 ± 7.4 months of follow-up. The mean final CRT significantly decreased from 384.4 ± 114.4 μm at baseline to 323.9 ± 77.7 μm (p = 0.0249). The mean final BCVA was 51.4 ± 21.3 letters, which was not significant compared to baseline (44.9 ± 30.2 letters, p = 0.1149). Mean IOP did not increase significantly. All patients tolerated the treatment well without serious adverse events. Higher baseline CRT and worse BCVA correlated with better therapeutic responses.Conclusion: Switching to DEX implant is effective and safe for treating DME non-responder to intravitreal ranibizumab in real world.

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Comparison of Intravitreal Ranibizumab and Aflibercept for the Treatment of Diabetic Macular Edema: A Real-World Study

10.21203/rs.3.rs-1076981/v1 ◽

2021 ◽

Author(s):

Puren Isik ◽

Selcuk Sizmaz ◽

Ebru Esen ◽

Anil Uysal ◽

Nihal Demircan

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Real World ◽

Treated Group ◽

Intravitreal Ranibizumab ◽

Significant Difference ◽

The Mean ◽

Retrospective Comparative Study ◽

Change In Mean

Abstract Purpose: To compare the visual and anatomic outcomes of intravitreal ranibizumab versus aflibercept in patients with diabetic macular edema (DME) in a real-world study.Methods: This is a single-center retrospective comparative study of treatment-naïve patients who received intravitreal ranibizumab or aflibercept administration for DME for at least 12 months on an as needed regimen following three-monthly loading doses. The primary outcomes of the study were the mean change in best-corrected visual acuity (BCVA), central macular thickness (CMT), central macular volume (CMV). Factors to potentially affect these parameters were also analyzed.Results: A total of 100 eyes (66 patients) were included in the study. Fifty two eyes received ranibizumab and 48 received aflibercept injections. While the decrease in mean CMT at the 4th-month visit was significantly higher in the aflibercept-treated group than in the ranibizumab-treated group (p=0.02), there was no difference between the two groups at the end of the one-year follow-up (p=0.25). There was no significant difference between the two groups in terms of change in mean CMV during the follow-up. (p=0.26, p=0.27 at 4 and 12 months, respectively). The mean number of injections were also similar between groups (4.5 ± 1 vs. 4.6 ± 1.1 respectively, p=0.63).Conclusion: In a real-world setting, ranibizumab and aflibercept were both found to be effective in the first-line treatment of DME. Patients with DME who received fewer injections in the real-world could achieve visual and anatomical results comparable to randomized controlled trials participants.

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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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Effect of Calcium Dobesilate (CaD) on Diabetic Macular Edema Treated by Intravitreal Ranibizumab

10.21203/rs.3.rs-830956/v1 ◽

2021 ◽

Author(s):

Dongxuan Wang ◽

Hui Wang ◽

Shuang Wu ◽

Xueqiu Yang ◽

Jiansen Xu

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Calcium Dobesilate ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

The Mean ◽

Pro Re Nata ◽

Dose Injection ◽

Control Study

Abstract Background: Calcium dobesilate (CaD) had been used in the treatment of diabetic retinopathy (DR) due to its potential in protecting against retinal vascular damage. However, it did not reduce the risk of development of diabetic macular edema (DME). The aim of this study was to investigate the effect of CaD plus intravitreal ranibizumab in the treatment of DME.Methods: This retrospective, observational, consecutive case control study enrolled patients newly diagnosed with DME who received intravitreal ranibizumab (IVR) administration with 3-monthly loading dose injection followed by pro re nata (3+PRN) regimen with or without CaD orally daily for at least 12-month follow-up. Medical records and optical coherence tomography (OCT) results were reviewed and compared at baseline and at 3, 6, and 12 months after injection.Results: A total of 102 eyes from 102 patients were enrolled in this study. Fifty-four patients received IVR combined with CaD orally (IVR+CaD group), while forty-eight patients received IVR solely (IVR group). No statistically significant differences were found in the general condition of patients between the two groups at baseline (P > 0.05). At every follow-up, 3, 6 and 12 months after injection, the best corrected visual acuity (BCVA) improved and the central macular thickness (CMT) decreased in both groups when compared with those at baseline (P < 0.05), while there were no significant differences in BCVA improvement and CMT reduction between the two groups (P > 0.05). The mean number of ranibizumab injections in R+C group was significantly lower than that in R group (5.4 ± 1.1 injections versus 6.7 ± 1.6 injections, P<0.05) within 1-year treatment. No adverse events were found in neither groups.Conclusions: Adding oral CaD to intravitreal ranibizumab was demonstrated to have similar effectiveness and safety for improving visual function and restoring the anatomy of the retina in macular with fewer injections in DME patients.

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The Effectiveness of Intravitreal Ranibizumab in Patients with Diabetic Macular Edema Who Have Failed to Respond to Intravitreal Bevacizumab

Ophthalmologica ◽

10.1159/000444103 ◽

2016 ◽

Vol 235 (3) ◽

pp. 133-136 ◽

Cited By ~ 7

Author(s):

Rita Ehrlich ◽

Idit Dan ◽

Iris Deitch ◽

Ruth Axer-Siegel ◽

Karin Mimouni

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Intravitreal Bevacizumab ◽

Tertiary Hospital ◽

Second Line ◽

Intravitreal Ranibizumab ◽

Second Line Therapy ◽

Line Therapy ◽

Intravitreal Treatment ◽

The Mean

Purpose: To investigate the response to intravitreal ranibizumab after failure of intravitreal bevacizumab in patients with diabetic macular edema (DME). Methods: Demographics, visual acuity (VA), central macular thickness (CMT), and HbA1C were retrospectively collected from DME patients treated with second-line intravitreal ranibizumab at a tertiary hospital in 2012-2013 and followed for at least 3 months. Results: Twenty-two patients (26 eyes) were included in the study, with a mean (±SD) age of 66 ± 8.1 years and followed for an average of 28.36 months. The mean number of intravitreal bevacizumab injections was 7.3 ± 2.8, and of intravitreal ranibizumab injections 5.11 ± 2.4. After 3 ranibizumab injections, 57% of eyes showed improvement in VA. The change in VA was statistically significant (p = 0.044) in those eyes where the pretreatment acuity for the second-line therapy was <20/40 (logMAR 0.3). CMT decreased from 435.95 ± 83.28 to 373.69 ± 44.39 µm (p = 0.01). The number of ranibizumab injections was significantly correlated with the change in CMT (p = 0.037). Conclusion: Intravitreal treatment with ranibizumab can be efficacious in eyes with DME that have failed to respond to bevacizumab.

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Visual Outcomes Following Intravitreal Ranibizumab for Diabetic Macular Edema in a Pro Re Nata Protocol from Baseline: A Real-World Experience

Asia-Pacific Journal of Ophthalmology ◽

10.22608/apo.2018413 ◽

2019 ◽

Cited By ~ 1

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Real World ◽

Intravitreal Ranibizumab ◽

Visual Outcomes ◽

Pro Re Nata

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Treatment strategies for refractory diabetic macular edema: switching anti-VEGF treatments, adopting corticosteroid-based treatments, and combination therapy

Expert Opinion on Biological Therapy ◽

10.1517/14712598.2016.1131265 ◽

2016 ◽

Vol 16 (3) ◽

pp. 365-374 ◽

Cited By ~ 27

Author(s):

Rehan M. Hussain ◽

Thomas A. Ciulla

Keyword(s):

Combination Therapy ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Treatment Strategies ◽

Anti Vegf ◽

Refractory Diabetic Macular Edema

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Sub-optimal gain in vision in retinal vein occlusion due to under-treatment in the real world: results from an open-label prospective study of Intravitreal Ranibizumab

BMC Ophthalmology ◽

10.1186/s12886-020-01757-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Raja Narayanan ◽

Aditya Kelkar ◽

Zahir Abbas ◽

Neha Goel ◽

Manoj Soman ◽

...

Keyword(s):

Clinical Trials ◽

Macular Edema ◽

Retinal Vein Occlusion ◽

Real World ◽

Intravitreal Injections ◽

Open Label ◽

Intravitreal Ranibizumab ◽

The Real ◽

Vein Occlusion ◽

The Mean

Abstract Background Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting. Methods This was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography. Results One hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye. Conclusions Ranibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment. Trial registration Clinical Trials Registry - India: CTRI/2015/07/005985.

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Pretreatment Neutrophil-to-Lymphocyte Ratio Predicts Prognosis in Patients with Diabetic Macular Edema Treated with Ranibizumab

10.21203/rs.2.9451/v2 ◽

2019 ◽

Author(s):

Yuxiang Hu ◽

Yi Cheng ◽

Xiaoxuan Xu ◽

Bo Yang ◽

Feng Mei ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Linear Regression Analysis ◽

Multiple Linear Regression Analysis ◽

Neutrophil To Lymphocyte Ratio ◽

Clinicopathological Parameters ◽

Intravitreal Ranibizumab ◽

Lymphocyte Ratio ◽

Treatment Naïve ◽

The Mean

Abstract Background: To investigate the prognostic value of the neutrophil-to-lymphocyte ratio (NLR) in patients with diabetic macular edema (DME) treated monthly with ranibizumab. Methods: We retrospectively analyzed the medical records of all patients who received intravitreal ranibizumab (IVR) treatment for DME at the First Affiliated Hospital of Nanchang University between December 2015 and December 2017. Clinicopathological parameters, including NLR, were evaluated to identify predictors of better outcomes of IVR monotherapy. Results: Ninety-one treatment-naïve eyes treated with IVR for DME were retrospectively analyzed in this study. Baseline best-corrected visual acuity (BCVA), neutrophils, NLR, monocyte-to-lymphocyte ratio, and platelet-to-lymphocyte ratio were negatively correlated with the changes in BCVA at 24 weeks compared with the baseline, while baseline central retinal thickness and lymphocytes were positively correlated with the changes in BCVA at 24 weeks compared with the baseline. Multiple linear regression analysis revealed that NLR was independently associated with the mean change of BCVA between baseline and week 24. In addition, patients with NLR < 2.27 showed a better improvement in letter score than those with NLR > 2.27. Conclusion: Pretreatment NLR is independently associated with the BCVA in DME patients treated with IVR, and higher pretreatment NLR may contribute to inferior BCVA outcomes.

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