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

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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Our 2-Year Real-Life Outcomes in Patients Who Received Ranibizumab Treatment for Diabetic Macular Edema (DME)

Bakirkoy Tip Dergisi / Medical Journal of Bakirkoy ◽

10.5222/bmj.2020.39200 ◽

2020 ◽

Author(s):

İsmail Umut Onur ◽

Mehmet Fatih Asula ◽

Ulviye Yiğit ◽

Ozan Sonbahar ◽

Utku Furuncuoğlu

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Real Life ◽

First Year ◽

Life Outcomes ◽

Intravitreal Ranibizumab ◽

Significant Difference ◽

The Mean ◽

Second Year ◽

Change In Mean

Objective: To assess the real-life performance and clinical outcomes in patients with diabetic macular edema (DME). Method: The chart records were retrospectively evaluated for 42 eyes of 42 patients with DME, who were followed for two years between October 2013 and October 2016 at the Retina Unit. The patients were treated using intravitreal ranibizumab (0.5 mg/0.05 ml) for two years. Results: The Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score indicated BCVA values of 71.1±22.4 letters at baseline, 74.1±19.1 letters at the sixth month, 76.2±16.2 letters at the first year, and 76.1±21.2 letters at the end of the second year. BCVA at the sixth month and first and second years were not significantly different from the baseline value (p=0.172, p=0.051, p=0.108). The mean CFT were 407.4±140.0 μm at the baseline, 375.5±141.5 μm at the 6th month, 357.0±129.1 μm at the 1st year, and 313.8±108.9 μm at the end of 2nd year. The change in mean CFT compared to the baseline value was not statistically significant at the 6th month, but were statistically significant at the 1st and the 2nd years (p=0.082, p=0.040, and p=0.000, respectively).The mean numbers of injections and follow-ups at the end of the second year were 3.7±2.5 and 9.1±3.1, respectively. Conclusion: The BCVA did not change significantly compared to baseline. The BCVA eye scores improved by 15 or more letters, in agreement with findings of other multi-center studies. However, the eyes with a BCVA loss of 15 or more letters showed a significant difference, which might reflect the smaller number of injections given in the present study compared to the other studies.

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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 Aflibercept and Ranibizumab following Initial Treatment with Ranibizumab in Persistent Diabetic Macular Edema

Journal of Ophthalmology ◽

10.1155/2018/4171628 ◽

2018 ◽

Vol 2018 ◽

pp. 1-5 ◽

Cited By ~ 6

Author(s):

Ali Demircan ◽

Zeynep Alkin ◽

Ceren Yesilkaya ◽

Gokhan Demir ◽

Burcu Kemer

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Medical Records ◽

Poor Response ◽

Intravitreal Aflibercept ◽

The Mean ◽

Retrospective Comparative Study ◽

Switch Group ◽

Persistent Diabetic Macular Edema

Purpose. To compare the visual and anatomic outcomes in patients with persistent diabetic macular edema (DME) who switched from ranibizumab to aflibercept with those who continued with previous ranibizumab therapy. Methods. In this retrospective comparative study, medical records of consecutive patients with center-involved DME ≥ 350 μm who had at least three recent consecutive monthly ranibizumab injections followed by as-needed therapy with either aflibercept or ranibizumab were reviewed. Data were collected at presentation (preinjection), at the intermediary visit, and at the last visit (at the end of the follow-up period). Results. Forty-three eyes of 43 patients were divided into two groups: the switch group (n=20) and the ranibizumab group (n=23). Though no significant improvement was found in the mean BCVA from the intermediary visit to the last visit, there was a difference in the mean CMT in the switch group and the ranibizumab group (p<0.001 and p=0.03, resp.). The mean CMT decreased after the intermediary visit by 188.6 ± 120.5 μm in the switch group and by 60.3 ± 117.1 μm in the ranibizumab group (p=0.003). Conclusions. Both aflibercept and ranibizumab decreased CMT in patients with persistent DME who showed a poor response to ranibizumab injections. However, switching to aflibercept provided only morphologic improvement.

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

Frontiers in Medicine ◽

10.3389/fmed.2021.649979 ◽

2021 ◽

Vol 8 ◽

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 ◽

Treatment Strategies ◽

Influential Factors ◽

Intravitreal Ranibizumab ◽

Multicenter Studies ◽

Serious Adverse Events ◽

Refractory Diabetic Macular Edema ◽

The Mean

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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Real-World Treatment Patterns and Vision Outcomes with Ranibizumab for Diabetic Macular Edema

Journal of Ophthalmology ◽

10.1155/2021/8825082 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Tadas Naujokaitis ◽

Vilma Jurate Balciuniene

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Real World ◽

Clinical Setting ◽

Retrospective Chart Review ◽

First Year ◽

Intravitreal Ranibizumab ◽

Second Year ◽

Gain Loss

Purpose. To assess injection patterns and vision outcomes in patients receiving intravitreal ranibizumab injections for diabetic macular edema in a real-world clinical setting. Methods. Retrospective chart review involving 74 eyes of 62 patients who started ranibizumab treatment for diabetic macular edema at the Hospital of the Lithuanian University of Health Sciences Kauno Klinikos. Data collected included follow-up visits, injections administered, and best-corrected visual acuity (BCVA). Results. Median follow-up duration was 652.5 days (min 365; max 914). Over the first year, eyes received a median of 4 injections (min 1; max 10). Among eyes with 2-year follow-up and injections during the second year, there was a median of 3 injections (min 1; max 6) over the second year. The BCVA improved by a median of 5 letters 365 ± 60 days and 730 ± 60 days after baseline. At the first visit ≥365 days after baseline, 13.5% of eyes gained ≥15 letters from baseline while 6.8% of eyes lost ≥15 letters. For 74.3% of eyes, BCVA improved (gain of ≥5 letters) or remained stable (gain/loss of ≤4 letters). Conclusion. Intravitreal ranibizumab for diabetic macular edema was effective in a real-world clinical setting, with most eyes gaining or maintaining vision. Compared with randomized prospective clinical trials, patients received less frequent injections and achieved lower vision gains.

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Panretinal photocoagulation after or prior to intravitreal conbercept injection for diabetic macular edema: a retrospective study

BMC Ophthalmology ◽

10.1186/s12886-021-01920-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Wei Zhang ◽

Guiyang Zhao ◽

Weijie Fan ◽

Taihong Zhao

Keyword(s):

Diabetic Retinopathy ◽

Retrospective Study ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Panretinal Photocoagulation ◽

Significant Difference ◽

Photocoagulation Treatment ◽

The Mean ◽

The Difference

Abstract Background Panretinal photocoagulation treatment (PRP) have been known as a standard treatment for proliferative diabetic retinopathy (PDR) or severe nonproliferative diabetic retinopathy (sNPDR). However, there is no consensus on when PRP should be administrated if anti-VEGF treatment is needed for the concurrent diabetic macular edema (DME). This study is to evaluate the difference between two groups of PRP prior to, or after intravitreal conbercept (IVC) for patients with PDR or sNPDR combined with DME. Methods This was a retrospective study. Fifty-eight eyes with DME secondary to PDR or sNPDR were divided into two groups; the PRP after (PRP-after group), or prior to (PRP-prior group), IVC. Changes in number of IVC injections, best corrected visual acuity (BCVA), and central subfield macular thickness (CSMT) were compared after 4 weeks, 12 weeks, 1 year, and 2 years from the first IVC injection. Results The mean number of injections in PRP-after group was 4.8 (1 year) and 6.4 (2 year), lower than 6.4 (1 year) and 8.5 (2 year) in PRP-prior group (both p = 0.002). There was no significant difference in change in BCVA and CSMT between two groups after each follow-up. Conclusion PRP after IVC requires less injections but also yields similar visual and anatomic outcome comparing with PRP prior to IVC in patients with diabetic retinopathy combined with DME.

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Effectiveness of Intravitreal Ranibizumab in Nonvitrectomized and Vitrectomized Eyes with Diabetic Macular Edema: A Two-Year Retrospective Analysis

Journal of Ophthalmology ◽

10.1155/2020/2561251 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Ozgun Melike Gedar Totuk ◽

Ayse Yagmur Kanra ◽

Mohammed Nadim Bromand ◽

Guler Kilic Tezanlayan ◽

Sevil Ari Yaylalı ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Medical Records ◽

Response To Treatment ◽

Intravitreal Ranibizumab ◽

Female Ratio ◽

Corrected Visual Acuity ◽

The Mean ◽

Male To Female

The aim of this study was to compare the effectiveness of intravitreal ranibizumab (IVR) injections for the treatment of diabetic macular edema (DME) in eyes with and without previous vitrectomy. The medical records of 28 eyes (11 vitrectomized and 17 nonvitrectomized) of 28 patients (mean age, 59.0 ± 9.6 years; male to female ratio 1 : 1) who were diagnosed with DME and had received IVR treatment were reviewed retrospectively. The indications of vitrectomy in 11 vitrectomized eyes were intravitreal hemorrhage (n = 8) and epiretinal membrane (n = 3). The best-corrected visual acuity (BCVA), central macular thickness (CMT), and total macular volume (TMV) were measured at baseline and at months 6, 12, 18, and 24 of the follow-up. The number of IVR injections, the duration between diagnosis of DME and IVR injection, and the hemoglobin A1c (HbA1c) level at baseline were also recorded. Baseline demographics, HbA1c, BCVA, CMT, and TMV values were similar between two groups (p>0.05). The duration between diagnosis of DME and IVR injections was similar in both groups (16 ± 5 months vs. 13 ± 4 months, respectively; p=0.11). IVR injection was performed 6.3 times in vitrectomized eyes and 6.1 times in nonvitrectomized eyes during the 24-month period (p>0.05). The mean BCVA improved significantly during the 24-month period in both groups. The improvements in BCVA, in CMT, and in TMV were more significant at month 6 (p=0.036) group, at month 12 (p=0.013), at month 12 (p=0.021), and month 24 (p=0.021) in nonvitrectomized eyes, respectively, while there was no difference in improvements of BCVA, CMT, and TMV in vitrectomized group at each visit. Treatment effected by time in terms of BCVA, CMT, and TMV values in all groups (p=0.0004, p<0.0001, p<0.0001, respectively), not by time-group interaction and group (all p values >0.05). In conclusion, IVR treatment for DME is equally effective in both groups. However, the response to treatment is seen earlier in nonvitrectomized eyes compared to vitrectomized eyes.

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Efficacy of posterior sub-Tenon’s capsule injection compared to intravitreal injection of triamcinolone acetonide for treatment of diabetic macular edema: A systematic review and meta-analysis

QJM ◽

10.1093/qjmed/hcab109.019 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Mohamed H Ibrahim ◽

Abdelrahman G Salman ◽

Azza M Said ◽

Mariam A Al-Feky ◽

Moustafa E Moustafa

Keyword(s):

Systematic Review ◽

Macular Edema ◽

Intravitreal Injection ◽

Triamcinolone Acetonide ◽

Diabetic Macular Edema ◽

Meta Analysis ◽

Significant Difference ◽

The Mean ◽

Iop Elevation

Abstract Background Diabetic macular edema (DME) is defined as a retinal thickening in one-disc diameter (DD) of the centre of the macula. It is a number of microvascular retinal changes that lead to blood–retinal barrier (BRB) disruption, causing leakage of fluid and plasma components into the inner and outer plexiform layers. Aim of the Work to conduct a systematic review and a meta-analysis estimating the efficacy and complications of posterior sub-Tenon’s capsule injection of triamcinolone acetonide (STTA) compared to intravitreal injection of triamcinolone acetonide (IVTA) for management of DME. Materials and Methods A comprehensive literature search was conducted using the databases Google scholar, PubMed, MEDS, web of science, EMBASE and Cochrane Library for published studies from 1 January 2000 to 1 September 2019.This meta-analysis included ten studies. They were randomized controlled clinical trials (RCTs), and about 343 patients with DME (469 eyes) participated in these studies. Results : This study demonstrated a statistically significant change in the mean of best corrected visual acuity (BCVA) improvement and central macular thickness (CMT) reduction in both groups when comparing the baseline to one- and three-month follow-ups after the injection, though with no statistically significant difference in the IVTA compared to the STTA group. At a six-month follow-up, both groups showed no significant differences in the BCVA and CMT compared to the baseline. Both groups showed no statistical differences in the BCVA or CMT over the follow-up periods. Regarding intraocular pressure (IOP) changes, the present study showed that the mean IOP was elevated in both groups at one- and three-month follow-ups after the injection compared to their baseline. There was a statistically significant difference between both groups at one and three-months. The IOP was more elevated in the IVTA compared to the STTA group. At a six-month follow-up, both groups showed no significant difference in the IOP elevation compared to the baseline. IOP elevation was the most reported adverse effect in all included studies. Cataract formation is also reported in some studies, though no other complications, such as endophthalmitis, vitreous hemorrhage (VH), and/or retinal detachment (RD), are reported in any of the studies. Conclusion : STTA injection has a comparable effect to the IVTA injection and carries a lower risk of intraocular complications. It is considered an easy, safe, and valid alternative to the intravitreal injection for the treatment of DME.

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Effectiveness of Intravitreal Ranibizumab in Nonvitrectomized and Vitrectomized Eyes with Diabetic Macular Edema: A Two-Year Retrospective Analysis

10.21203/rs.2.9466/v2 ◽

2019 ◽

Author(s):

Ozgun Melike Gedar Totuk ◽

Ayse Yagmur Kanra ◽

Mohammed Nadim Bromand ◽

Guler Kilic ◽

Sevil Ari Yaylali ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Response To Treatment ◽

Intravitreal Ranibizumab ◽

Female Ratio ◽

Corrected Visual Acuity ◽

Baseline Values ◽

The Mean ◽

Male To Female

Abstract Background: To compare the effectiveness of intravitreal ranibizumab (IVR) injections for the treatment of diabetic macular edema (DME) in eyes with and without previous vitrectomy. Methods: The medical records of 30 eyes (13 vitrectomized, 17 nonvitrectomized) of 28 patients (mean age, 59.0±9.6 years; male to female ratio 1:1) who were diagnosed with DME and had received IVR treatment were reviewed retrospectively. The indications of vitrectomy in 13 vitrectomized eyes were intravitreal hemorrhage (n=8), vitreomacular traction (n=1), and epiretinal membrane (n=4). The best-corrected visual acuity (BCVA), central macular thickness (CMT), and total macular volume (TMV) were measured at baseline and at months 6, 12, 18, and 24 of the follow-up. The number of IVR injections, the duration between diagnosis of DME and IVR injection, and hemoglobin A1c ( HbA1c ) level at baseline were also recorded. Retreatment criteria included persistence of submacular fluid, intraretinal cysts, or CMT of more than 300 μm. Results: Baseline demographics, HbA1c, BCVA, CMT, and TMV values were similar between the vitrectomized and nonvitrectomized groups (p>0.05). The duration between diagnosis of DME and IVR injections was longer in the nonvitrectomized group than in the vitrectomized group (16±5 months vs. 13±4 months, respectively; p=0.045). IVR injection was performed 6.3 times in vitrectomized eyes and 6.1 times in nonvitrectomized eyes during the 24-month period (p>0.05). The mean BCVA improved significantly during the 24-month period in both groups (for vitrectomized group from 0.51±0.26 logMAR to 0.40±0.22 logMAR; for nonvitrectomized group from 0.72±0.28 logMAR to 0.50±0.22 logMAR). The improvement in BCVA was significant at month 6 in nonvitrectomized eyes, while there was no significant improvement in vitrectomized eyes before month 18. Compared to the baseline values, the decrease in both CMT and TMV was significant in months 6, 12, 18, and 24 in the nonvitrectomized group (p<0.05). In the vitrectomized group both CMT and TMV improved significantly only in months 18 and 24 (p<0.05). Conclusion: IVR treatment for DME is equally effective in both vitrectomized and nonvitrectomized eyes. However, the response to treatment is seen later in vitrectomized eyes compared to nonvitrectomized eyes.

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