Injection For Diabetic Macular Edema Research Articles

Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema

There are reported benefits from vitrectomy for diabetic macular edema (DME); however, data precede anti-vascular endothelial growth therapy (VEGF) therapy, supporting a need to assess the current role of vitrectomy. To determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&E) anti-VEGF injections for diabetic macular edema (DME). This was a single-masked, multicenter randomized clinical trial at 21 sites in the United Kingdom from June 2018 to January 2021, evaluating single eyes of treatment-naive patients with symptomatic vision loss from DME for less than 1 year. Inclusion criteria were best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score greater than 35 (approximate Snellen equivalent, 20/200 or better) and central subfield thickness (CST) greater than 350 μm after 3 monthly intravitreal injections of ranibizumab or aflibercept. Data analysis was performed in July 2023. Patients were randomized 1:1 into vitrectomy plus standard care or standard care alone and further stratified into groups with vs without vitreomacular interface abnormality. Both groups received a T&E anti-VEGF injection regimen with aflibercept, 2 mg, or ranibizumab, 0.5 mg. The vitrectomy group additionally underwent pars plana vitrectomy with epiretinal membrane or ILM peel within 1 month of randomization. Rate of recruitment and distance BCVA. Secondary outcome measures were CST, change in BCVA and CST, number of injections, rate of completed follow-up, and withdrawal rate. Over 32 months, 47 of a planned 100 patients were enrolled; 42 (89%; mean [SD] age, 63 [11] years; 26 [62%] male) completed 12-month follow-up visits. Baseline characteristics appeared comparable between the control (n = 23; mean [SD] age, 66 [10] years) and vitrectomy (n = 24; mean [SD] age, 62 [12] years) groups. No difference in 12-month BCVA was noted between groups, with a 12-month median (IQR) BCVA letter score of 73 (65-77) letters (Snellen equivalent, 20/40) in the control group vs 77 (67-81) letters (Snellen equivalent, 20/32) in the vitrectomy group (difference, 4 letters; 95% CI, -8 to 2; P = .24). There was no difference in BCVA change from baseline (median [IQR], -1 [-3 to 2] letters for the control group vs -2 [-8 to 2] letters for the vitrectomy group; difference, 1 letter; 95% CI, -5 to 7; P = .85). No difference was found in CST changes (median [IQR], -94 [-122 to 9] μm for the control group vs -32 [-48 to 25] μm for the vitrectomy group; difference, 62 μm; 95% CI, -110 to 11; P = .11). Enrollment goals could not be attained. However, with 47 participants, evidence did not support a clinical benefit of vitrectomy plus ILM peeling as an adjunct to a T&E regimen of anti-VEGF therapy for DME. isrctn.org Identifier: ISRCTN59902040.

Changes in Ocular Blood Flow After Intravitreal Injection for Diabetic Macular Edema Between Aflibercept and Faricimab.

In this study, we aimed to evaluate and compare the effects of intravitreal aflibercept (IVA) and intravitreal faricimab (IVF) injections on the blood flow of retinal vessels in the peripapillary region and optic nerve head (ONH) in eyes with diabetic macular edema (DME) using laser speckle flowgraphy (LSFG). This study included 20 eyes of 18 patients treated with IVA and 15 eyes of 11 patients treated with IVF for DME. The mean blur rate (MBR) of the ONH and retinal artery and vein of the peripapillary region were measured using LSFG at baseline and 1 month after injection. Central retinal thickness (CRT) and best-corrected visual acuity (BCVA) were measured for all patients. CRT decreased significantly in both IVA-treated (p = 0.0003) and IVF-treated groups (p = 0.0004). Some of the MBR-related parameters of the ONH, such as MBR of all areas (MA), MBR of vascular areas (MV), and MBR of tissue areas (MT), decreased significantly 1 month after IVA and IVF compared to baseline values (MA of IVA, p < 0.0001; MT of IVA, p = 0.0220; MA of IVF, p = 0.0002; MT of IVF, p = 0.0461). MBR of the retinal artery (MBR-A) and vein (MBR-V) also decreased significantly 1 month after IVA and IVF compared with baseline values (MBR-A of IVA, p = 0.0002; MBR-V of IVA, p = 0.0010; MBR-A of IVF, p = 0.0368). No significant difference in ocular perfusion was observed between the IVA-treated and IVF-treated groups. Intravitreal injection led to a reduction in ocular blood flow in both retinal peripapillary vessels and the ONH in both IVA-treated and IVF-treated groups. No significant difference was observed in MBR reduction between the IVA-treated and IVF-treated groups. Our findings warrant further long-term investigations to reveal differences between aflibercept and faricimab.

Evaluation of Anxiety Levels in Patients Undergoing Intravitreal Injection for Diabetic Macular Edema

Objective: In this study, we aimed to analyze the anxiety levels of patients regarding intravitreal injection (IVI) using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and to evaluate the effect of repeated injections on anxiety levels. Methods: Between September 01, 2023 and January 10, 2024, 85 patients who underwent intravitreal anti-vascular endothelial growth factor injection for diabetic macular edema in our clinic were included in this study. Results: According to APAIS scores, mean anesthesia anxiety was 5.4±2.6, surgical anxiety was 5.1±2.6 and total anxiety score was 10.5±3.7. Anesthesia information need was 2.7±0.95, surgical information need was 2.6±1.14 and total information need score was 5.3±1.50. There was no significant difference between genders in terms of total and subgroup scores (p&gt;0.05, all). No significant correlation was found in the correlation analysis between age and number of injections and APAIS scores (subdimensions and total) (p&gt;0.05, all). Conclusion: In conclusion, the potential anxiety of patients before and during intravitreal injection should be considered. In addition, since IVI often involves repeated treatments, it is of great importance to identify modifiable factors that may reduce anxiety. Given the importance of compliance, premedication may be considered to reduce anxiety, especially in high-risk (high preoperative anxiety) patients. Comprehensive explanations about treatment and well-structured processes are crucial for long-term adherence to anti-VEGF therapy.

Macular Ischemia Changes in Patients with Diabetic Macular Edema Treated with Aflibercept and Ranibizumab.

Τhis study aims to assess changes in the fovea avascular zone (FAZ) in treatment naïve patients receiving aflibercept or ranibizumab injections for diabetic macular edema (DME). Best corrected visual acuity (BCVA) testing, OCT, and OCT-angiography imaging were performed at baseline and 1 month after each injection. Injections of either aflibercept or ranibizumab were administered monthly for 6 consecutive months. FAZ in the superficial (SCP) and the deep capillary plexus (DCP) using OCT angiography was recorded for each visit. Fifty eyes from fifty patients with a mean age of 67.0 ± 10.7 years were included in the study. Twenty-five patients received aflibercept and twenty-five received ranibizumab. BCVA was 40.8 ± 10.0 and increased to 52.1 ± 7.9 ETDRS letters at the last visit (p < 0.001). CRT was 295.6 ± 34.0 at baseline and 247.9 ± 29.7 at the last study visit (p < 0.001). SCP FAZ was 350.6 ± 79.5 μm2 at baseline and 339.0 ± 71.3 μm2 after sox monthly injections (p = 0.132). DCP FAZ was 558.6 ± 199.0 μm2 at baseline and 459.5 ± 156.1 μm2 after six monthly injections (p < 0.001). There was no effect of the choice of ranibizumab or aflibercept on DCP FAZ change (p = 0.277). In conclusion, treatment with 6 monthly injections of ranibizumab and aflibercept led to an increase in BCVA and a decrease in CRT and DCP FAZ area. Both drugs led to an improvement in DCP ischemia.

Rahnella Aquatilis Endophthalmitis after Intravitreal Injection in an Immunocompetent Patient.

To present a novel case of exogenous Rahnella aquatilis endophthalmitis following an intravitreal injection. Case report. A 74-year-old male presented with acute progressive vision loss and pain in the left eye, 5 days after an intravitreal injection for diabetic macular edema. The patient was diagnosed with exogenous endophthalmitis and empirically treated with intravitreal injections of vancomycin and ceftazidime as well as topical and oral ciprofloxacin. In follow up two days later, the patient was treated with preoperative povidone-iodine followed by prompt vitrectomy with additional vancomycin and ceftazidime due to pharmacy sterile hood issues that delayed antibiotic availability. Microbiological cultures and two mass spectrometry identification tests confirmed the diagnosis of exogenous Rahnella aquatilis endophthalmitis. Despite the presence of scattered retinal hemorrhagic infarcts involving the macula and subsequent full-thickness atrophic macular holes seen in follow up, the patient achieved a favorable anatomical and functional outcome of BCVA 20/80 at 1 year of follow-up. This case highlights the occurrence of exogenous Rahnella aquatilis endophthalmitis following an intravitreal injection for diabetic macular edema. Prompt diagnosis and treatment produced a favorable outcome relative to other typical Gram-negative Enterobacteriaceae organisms.

Comparison of intravitreal preservative-free triamcinolone versus posterior sub-tenon triamcinolone acetonide injection for bevacizumab-resistant diabetic macular edema

BackgroundTriamcinolone acetonide (TA) is administered as an intravitreal or posterior sub-Tenon’s capsule injection, as treatment for diabetic macular edema (DME). The intravitreal use of TA is limited because commercially available triamcinolone acetonide contains benzyl alcohol, a neurotoxic preservative. Few studies have compared effects of preservative-free intravitreal TA (IVTA) and posterior sub-Tenon capsule TA (STTA) injections for DME. Thus, herein, we compared the effectiveness of preservative-free IVTA and STTA for treatment of bevacizumab-resistant DME.MethodsIn this retrospective cohort study, bevacizumab-resistant DME was defined as a lack of response to at least three consecutive intravitreal bevacizumab (IVB) injections. Changes in mean central macula thickness (CMT), best-corrected visual acuity (BCVA), and intraocular pressure (IOP) between IVTA and STTA groups were compared at baseline and at 1, 2, and 3 months after treatment.ResultsForty eyes from 40 patients were included in this study. In the IVTA group, the mean CMT improved significantly from 400.2 ± 144.42 μm at baseline to 288.35 ± 151.74 μm at 3 months after treatment (p = 0.01). Similarly, in the STTA group, the mean CMT improved significantly from 446.65 ± 120.74 μm at baseline to 382.9 ± 113.58 μm at 3 months after treatment (p = 0.009). The mean BCVA of the IVTA group also showed improvement, decreasing from 0.75 ± 0.55 logarithm of the minimum angle of resolution (logMAR) at baseline to 0.625 ± 0.50 logMAR at 3 months after treatment (p = 0.089). Similarly, the mean BCVA of the STTA group improved, from 0.6 ± 0.36 logMAR at baseline to 0.54 ± 0.35 logMAR at 3 months after treatment (p = 0.094).ConclusionGiven that IVTA and STTA demonstrated statistically equivalent anatomical and functional effects in patients with bevacizumab-resistant DME, the less invasive STTA may be considered the preferred treatment approach for the management of bevacizumab-resistant DME.Trial registrationRetrospectively registered.

Effects of repeated intravitreal bevacizumab administration on anterior segment parameters and limbal stem cells

Background: Macular edema (ME) is fluid accumulation in the macula caused by vascular leakage. Repeated intravitreal bevacizumab (IVB) injections are extensively used to treat ME of different origins, are well tolerated, and have few side effects. This study evaluated the effects of repeated IVB injections on the anterior segment parameters and limbal stem cells (LSCs) in eyes with ME.&#x0D; Methods: This before–after study involved patients with ME of different causes who underwent repeated IVB injections at the Imam Khomeini Ophthalmology Center in Kermanshah, Iran. Before and after repeated IVB injections, anterior segment parameters were measured using anterior segment optical coherence tomography, and the LSCs were assessed using impression cytology.&#x0D; Results: We enrolled 42 eyes of 42 patients with a mean (standard deviation [SD]) age of 59.6 (7.6) years, of whom 25 (59.5%) were men and 17 (40.5%) were women. The underlying diseases included diabetic ME in 30 eyes (71.4%), central (5 [11.9%]) or branch (3 [7.1%]) retinal vein occlusion, and choroidal neovascularization in 4 eyes (9.5%). The right eye was affected in 22 (52.4%) participants. The mean (SD) number of IVB injections was 4.3 (1.3). After repeated injections, the mean central corneal thickness (CCT) increased, whereas the mean anterior chamber angle (ACA) and anterior chamber depth (ACD) decreased (all P&lt;0.001). Three patients developed LSC deficiency after repeated IVB injections for diabetic ME.&#x0D; Conclusions: We observed a significant increase in the mean CCT and a decrease in the mean ACA and ACD after repeated IVB injections in our series. Three patients developed LSC deficiency after repeated IVB injections for diabetic ME management. The observed effect on LSC may cast doubt on the safety of repeated IVB injections; however, this finding must be verified in multicenter clinical trials with longer follow-up periods and larger study samples.

Prevalence and Visual Consequences of Non-adherent Patients Receiving Anti-vascular Endothelial Growth Factor (VEGF) Injections at King Fahad Specialist Hospital (KFSH), Qassim Region.

Anti-vascular endothelial growth factor (VEGF) injection treatment is a widely utilized therapy for various retinal diseases, including diabetic macular edema (DME). Therefore, the importance of compliance and follow-up should be discussed with the patient. There have been no studies conducted in the Qassim region to estimate the prevalence of patients missing their anti-VEGF appointments. To fulfill this need, we conducted this study to evaluate the compliance rate of patients treated with anti-VEGF injections for DME as well as to determine the visual consequences of the delay in anti-VEGF treatment in the Qassim region. This observational retrospective cohort study was conducted at King Fahad Specialist Hospital (KFSH) in the Qassim region of Saudi Arabia. We extracted all file numbers of patients who were using intravitreal anti-VEGF injections to treat DME. The data were managed and analyzed using the IBM Statistical Package for the Social Sciences (SPSS) software (IBM Corp., Armonk, NY, USA). In the current study, we were able to collect data from 198 patients who received anti-VEGF treatment in the hospital. Among the participants, 57.6% were male, with a mean age of 61.7 years old (standard deviation (SD) = 10.23). Among the patients, we found that the rate of non-adherence to the anti-VEGF injection was 54.5%, and those patients delayed their scheduled doses for more than 56 days. In 47.5% of the patients, delaying or stopping their appointments had no known reason; however, blepharitis was the main reason for delaying or stopping the dose in 27.7% of the patients, followed by endophthalmitis in 18.7% of the patients. There is no significant difference between before and after stopping the treatment, considering visual acuity (VA) or optical coherence tomography (OCT). However, regarding the disease progression, we found that 15 out of the 30 patients had worsened in the OCT after they missed their injections (mean increase in the VA was 6.069 (SD = 97.45), t = -0.278, P = 0.783, and decrease in the OCT was -14.9667 (SD = 133.87, P = 0.454). There is a high rate of patients who missed their appointments for an anti-VEGF injection. This resulted in the worsening of OCT in half of the 30 patients who were enrolled in the visual consequences study, which had a negative impact on treatment and disease progression.

Aflibercept for Diabetic Macular Edema in Real-Life Practice in GREece: Three-Year Outcomes of the ADMIRE Study

ABSTRACT Purpose To evaluate the efficacy and safety of intravitreal aflibercept injections for diabetic macular edema (DME) treatment in a tertiary referral center in Greece. Methods ADMIRE was a prospective, observational cohort study of patients with DME. Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to month 36 after treatment with intravitreal aflibercept in treatment-naive patients and previously treated patients. Safety was evaluated by recording any patients-reported events. Results Participants in the study were 94 patients with DME, 70 treatment naive and 24 previously treated with ranibizumab. At month 36 of the follow-up period, the mean change in BCVA was +7.4 letters compared to baseline (p < .001). The mean change in BCVA in treatment-naive patients was +8.9 letters and differed significantly compared to previously treated patients (+5.9 letters, p = .041). In addition, patients who received a loading dose of 5 monthly injections at the initiation of treatment provided better VA outcomes (+11.4 vs. +6.1 letters, p < .001). Accordingly, the mean CST at month 36 (369.6 ± 72.8 μm) was significantly decreased compared to baseline (479.2 ± 68.3 μm, p < .001). Overall, the mean number of injections at month 36 was 13.4. Safety analysis showed that the reported ocular adverse events during the 36-month study period were mild and not sight-threatening. Conclusion Intravitreal aflibercept was found to be safe and effective for the treatment of DME in real-life in a Greek population. Treatment-naive patients and those who received a loading dose of five consecutive monthly injections at initiation of treatment exhibited better outcomes, suggesting that early and effective treatment may prevent vision loss.

Retinal changes after fluocinolone acetonide implant (ILUVIEN®) for DME: SD-OCT imaging assessment using ESASO classification.

A detailed understanding of the anatomical and structural changes occurring in the retina following intravitreal fluocinolone acetonide implantation may help improve the management and prognosis of persistent or recurrent diabetic macular edema (DME). Overall, 45 eyes (from 35 patients) with refractory center-involved DME received an intravitreal fluocinolone acetonide implant. They were monitored at baseline and at 6, 12, 24, and 36 months for best-corrected visual acuity (BCVA), central foveal thickness (CFT), and the seven retinal parameters used in the classification of diabetic maculopathy recently developed at the European School for Advanced Studies in Ophthalmology (ESASO). Within 6 months of implantation, significant improvements were evident in BCVA, CFT, maculopathy stage, and the percentage of eyes with: intraretinal cysts; CFT > 30% above the upper normal value; and disrupted or absent ellipsoid zone (EZ) and/or external limiting membrane (ELM). Significant improvements were still maintained at 36 months post-implantation. At month 36, early treatment with the implant (i.e., after < 6 previous intravitreal injections for DME) trended toward being more effective than later treatment in improving BCVA, CFT, maculopathy stage, and the percentage of eyes with CFT > 30% above the upper normal value. However, statistical significance was not achieved. In persistent or recurrent DME, fluocinolone acetonide implantation can be effective in improving maculopathy stage and reducing the percentage of eyes with: intraretinal cysts; CFT > 30% above the upper normal value; and disrupted or absent EZ and/or ELM. It can also increase BCVA and reduce CFT.

Pro re nata Treatment of Diabetic Macular Edema with Cycles of Three Injections of Anti-vascular Endothelial Growth Factor Injections

PURPOSE: The purpose of this study was to report the visual and anatomic results at 12 and 24 months using the protocol of 3 monthly pro re nata (PRN) injections for diabetic macular edema (DME). METHODS: This was a retrospective chart review of 97 eyes with DME treated with a protocol of cycles consisting of 3 monthly injections of anti-vascular endothelial growth factor drugs on a PRN basis. Change in visual acuity was the main outcome measure. Macular thickness, number of injections, cycles, and visits in years 1 and 2 of follow-up were secondary outcomes. RESULTS: Ninety-six patients with a mean age of 60.9 ± 9.96 years were followed for a mean of 22.17 ± 12.30 months. Ninety-two (95.9%), 3 (3%), and 1 (1%) patients were started on bevacizumab, ranibizumab, and aflibercept, respectively. Of bevacizumab patients, 17 (18.2%) were eventually switched to aflibercept. The mean 12-month improvement (standard deviation [SD]) was + 3.3 (17.4) letters (95% confidence interval [CI] = +0.36–+7.05, P &lt; 0.001) after an average (SD) of 5.97 (2.98) injections over a mean (SD) of 1.7 (1.0) three-injection cycles. The mean 24-month improvement (SD) was + 5.6 (13.0) letters (95% CI: −0.28–11.05, P = 0.0186) after an average (SD) of 8.72 (6.31) injections over a mean (SD) of 2.9 (2.1) three-injection cycles. The mean central macular thickness (SD) at baseline, 12 months, and 24 months was 374 ± 120, 322 ± 88, and 305 ± 70 µm. Optical coherence tomography was fluid free at 12 and 24 months in 27.6% and 46% of eyes, respectively. CONCLUSION: Comparable to real-world studies, this protocol can stabilize or improve vision in more than 85% of DME patients over 24 months. The most important factor in improvement of vision is increasing number of injections and visits.

Real-World Persistence and Treatment Interval in Patients with Diabetic Macular Edema Treated with Anti-Vascular Endothelial Growth Factors in the USA.

There is little understanding of long-term treatment persistence in patients receiving anti-vascular endothelial growth factor (anti-VEGF) injections for diabetic macular edema (DME), particularly relating to treatment intervals. The aim of this study was to investigate the association between treatment interval and discontinuation rate after 24months of unilateral anti-VEGF treatment in patients with DME under routine clinical care in the USA. This was a non-interventional, retrospective cohort study to review the health insurance claims of adults with DME linked with the IBM MarketScan® Commercial and Medicare Supplemental databases, who were continuously enrolled in a health plan for at least 6months prior to their first anti-VEGF treatment and for a duration of at least 24months between July 2011 and June 2017. Patients were grouped on the basis of the injection interval they achieved at 24months of treatment. Discontinuation rate beyond 24months and its association with treatment intervals at 24months was estimated using the Kaplan-Meier method and Cox proportional hazards models. The overall discontinuation rate among the 1702 eligible patients from 24 to 60months after treatment initiation was 30%. At 60months, patients were more likely to remain on treatment in shorter (75.3% [4-week interval group]) versus longer treatment interval groups (62.1% [> 12-week interval group], difference = 13.2%, [95% confidence interval (CI) 1.06, 2.06], p = 0.01). Patients on a > 12-week interval were twice as likely to discontinue treatment compared with those on an 8-week interval (hazard ratio = 2.01 [95%CI 1.43, 2.82], p < 0.001). Patients with DME on longer anti-VEGF treatment intervals at 24months consistently had higher discontinuation rates in the following years than those on shorter treatment intervals.

Predictive factors for treatment outcomes with intravitreal anti-vascular endothelial growth factor injections in diabetic macular edema in clinical practice

BackgroundIntravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are the standard of care for diabetic macular edema (DME), a common complication of diabetes. This study aimed to identify factors influencing DME intravitreal anti-VEGF treatment outcomes in real-world practice.MethodsThis was a multi-center retrospective observational study using medical chart review of participants receiving anti-VEGF injections for DME (N = 248). Demographic and clinical variables were assessed for association with best corrected visual acuity (BCVA) and central macular thickness (CMT) outcomes using regression models.ResultsThere was a significant improvement in BCVA (p < 0.001) and CMT (p < 0.001) after 12 months of treatment, although 21% of participants had decreased BCVA, and 41% had a < 10% CMT reduction at 12 months. Higher baseline BCVA (p = 0.022, OR=-0.024, 95% CI=-0.046,-0.004) and longer duration of diabetic retinopathy (p = 0.048, OR=-0.064, 95% CI=-0.129,-0.001) were negative predictors for BCVA response, whereas Aflibercept treatment (p = 0.017, OR = 1.107, 95% CI = 0.220,2.051) compared with other drugs and a positive “early functional response” (p < 0.001, OR=-1.393, 95% CI=-1.946,-0.857) were positive predictors. A higher baseline CMT (p < 0.001, OR = 0.019, 95% CI = 0.012,0.0261) and an “early anatomical response”, (p < 0.001, OR=-1.677, 95% CI=-2.456, -0.943) were predictors for greater reduction in CMT. Overall, the variables could predict only 23% of BCVA and 52% of CMT response.ConclusionsThe study shows a significant proportion of DME patients do not respond to anti-VEGF therapy and identifies several clinical predictors for treatment outcomes.Trial registrationThe study was approved through the Human Research Ethics Committee, University of Tasmania (approval number H0012902), and the Southern Adelaide Clinical Human Research Ethics Committee (approval number 86 − 067).

Associations and Prognostic Significance of Fluctuations in Diabetic Retinopathy Severity in Eyes Treated for Diabetic Macular Edema

Introduction: The aim of our study was to investigate factors associated with diabetic retinopathy (DR) severity fluctuations in patients undergoing intravitreal injections for diabetic macular edema and to explore risk factors for proliferative DR (PDR). Methods: We graded ultra-widefield fundus photography imaging at each visit using the Early Treatment Diabetic Retinopathy Study Severity Scale (DRSS). We calculated the deviation from the mode (DM) of DRSS values as a proxy of DR severity fluctuations, and we analyzed its clinical associations with linear models. We computed risk factors for PDR with Cox hazard models. We included the DRSS area-under-the-curve (AUC) of DRSS scores as a covariate in all analyses. Results: We included 111 eyes with a median follow-up of 44 months. Higher DRSS-AUC values (β = +0.03 DRSS DM for unitary DRSS/month increase, p = 0.01) and a higher number of anti-VEGF injections (β = +0.07 DRSS DM for injection, p = 0.045) were associated with wider DR severity fluctuations. Higher DRSS-AUC values (HR = 1.45 for unitary DRSS/month increase, p = 0.001) and wider DR severity fluctuations (HR = 22.35 4th quartile vs. 1st–3rd quartile of DRSS DM, p = 0.01) were risk factors for PDR. Conclusion: Patients with larger DR variability in response to intravitreal injections may be at higher risk of DR progression. We advocate attentive follow-up in these patients to recognize PDR early.

Short-Term Outcomes of Intravitreal Faricimab Injection for Diabetic Macular Edema.

Background and Objectives: Faricimab is a novel bispecific antibody with Fab regions inhibiting both vascular endothelial growth factor-A and angiopoietin-2. Therefore, this study aimed to obtain short-term outcomes of intravitreal injection of faricimab (IVF) for the treatment of diabetic macular edema (DME) in daily clinical practice. Materials and Methods: A retrospective review was carried out on consecutive patients with DME who had been treated with IVF and were followed up for at least 1 month. Outcome measures included changes in logMAR best-corrected visual acuity (logMAR BCVA), central retinal thickness (CRT), number of IVF administrations, and safety. Clinical outcomes were also compared between the treatment-naïve and switch groups. Results: A total of 21 consecutive DME eyes from 19 patients were identified. The mean number of IVFs was 1.6 ± 0.8 during the mean follow-up time of 5.5 months. The overall mean logMAR BCVA following IVF was 0.236, 0.204, 0.190, and 0.224 at baseline, 1, 3, and 6 months, respectively, without a significant change from baseline to 1 month (p = 0.176) or for 6 months (p = 0.923). The overall mean CRT (μm) following IVF was 400.6, 346.6, 342.1, and 327.5 at baseline, 1, 3, and 6 months, respectively. CRT significantly decreased from baseline to 1 month (p = 0.001) but did not reach a significant level over 6 months following IVF (p = 0.070). No significant difference in BCVA or CRT was observed between the treatment-naïve and switch groups. No serious safety concerns were noted. Conclusions: IVF for the treatment of DME may preserve visual acuity and improve macular thickness without serious safety concerns in the short term in a real-world clinical setting.

Clinical Application of Intravitreal Aflibercept Injection for Diabetic Macular Edema Comparing Two Loading Regimens.

Background and Objectives: We investigated and compared the efficacy of three and five monthly loading regimens of an intravitreal aflibercept injection (IVA) in patients with diabetic macular edema (DME). Materials and Methods: This was a retrospective study that included patients diagnosed with DME and treated with an either three or five monthly aflibercept loading regimen from July 2018 to March 2022. Information on clinical characteristics and changes in the central retinal thickness (CRT) were obtained from medical records. Results: In total, 44 eyes of 44 patients with DME treated with IVA were included in this study, with 30 eyes treated with 3-monthly loadings (three-loading group) and 14 eyes with 5-monthly loadings (five-loading group). The mean CRT significantly decreased from the baseline one month after loading in both the three-loading and five-loading groups (p < 0.001). Four cases were refractory to treatment in the three-loading group, while there were no cases of refractory DME in the five-loading group. The stability rate was significantly higher in the five-loading group at three months after loading (p = 0.033). Conclusions: Five-monthly loading regimens of IVA might be favorable for DME considering the rate of refractory cases, stable duration, and the importance of early responsiveness to IVA in DME.

Surgical removal of dexamethasone implant (Ozurdex) accidentally injected inside crystalline lens

AbstractPurpose: To present a rare case of accidental injection of dexamethasone implant (Ozurdex) into crystalline lens in a patient with diabetic macular edema, which was surgically removed by uneventful phacoemulsification.Methods: A 41‐year‐old male patient had been treated with multiple aflibercept intravitreal injections for diabetic macular edema in his right eye, but he showed suboptimal response. So, we decided to treat this patient with intravitreal injection of Ozurdex. The implant was inadvertently injected inside the lens. Subcapsular cataract was formed during the course of 3 weeks at the precise site of the insertion and there was an increase of intraocular pressure, which was addressed with topical anti‐glaucoma medication. Despite all that, the macular edema regressed.Results: We performed cataract surgery and simultaneous removal of the Ozurdex implant 3 months after the injection. Phacoemulsification was completed without any complications as the posterior capsule remained intact the entire surgical time and the one‐piece intraocular lens was successfully placed in the bag.Conclusions: The injection of intravitreal dexamethasone implant (Ozurdex) into the crystalline lens is a rare complication that can be effectively managed with the surgical extraction of the implant from the lens and implantation of a one‐piece intraocular lens in the posterior chamber in the bag without any complications.

Impact of the COVID-19 Pandemic on Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Japan.

Anti-vascular endothelial growth factor (VEGF) therapy for diabetic macular edema (DME) improves visual acuity. However, repeated injections during routine outpatient visits are required to maintain this effect. The recent sudden global outbreak of coronavirus disease 2019 (COVID-19) had a major impact on daily life, including medical care, such as the provision of VEGF therapy. We retrospectively investigated the relationship between the number of anti-VEGF injections for DME and the number of new COVID-19-positive patients at 23 centers in Japan. We also surveyed ophthalmologists regarding the impact of the COVID-19 pandemic on anti-VEGF therapy. In the third and fourth waves of the pandemic, when the number of infected patients increased, the number of injections significantly decreased. In the first, third, and fourth waves, the number of injections increased significantly during the last month of each wave. Approximately 60.9% of ophthalmologists reported that the number of injections decreased after the pandemic. Of the facilities, 52.2% extended the clinic visit intervals; however, there was no significant difference in the actual number of injections given between before and after the pandemic. Although the number of injections temporarily decreased, Japanese ophthalmologists maintained the total annual number of anti-VEGF injections for DME during the pandemic.

Changes in metamorphopsia following intravitreal aflibercept injection for diabetic macular edema

The aim of the present study was to investigate changes in metamorphopsia in patients with diabetic macular edema (DME) following intravitreal aflibercept injection (IVA) with the treat and extend (TAE) regimen for a year. We performed a post hoc analysis of a multicenter, open-label, single-arm, prospective study. The study included 20 patients with DME. All eyes received 3 monthly loading injections of 2 mg aflibercept, followed by a TAE regimen. Every visit, the severity of metamorphopsia and the best-corrected visual acuity (BCVA) were evaluated, and optical coherence tomography (OCT) images were obtained. The severity of metamorphopsia was measured using M-CHARTS. The metamorphopsia scores before treatment and at 1, 2, 3, 6 and 12 months following treatment were 0.25 ± 0.23, 0.21 ± 0.15, 0.19 ± 0.23, 0.14 ± 0.16, 0.17 ± 0.20 and 0.10 ± 0.17, respectively, with significant improvement from before treatment to 3 and 12 months following treatment (p < 0.05 and p < 0.005, respectively). At the time of macular edema resolution, the presence of an epiretinal membrane (ERM) was associated with the metamorphopsia score (p < 0.05). In conclusion, the metamorphopsia score in patients with DME improved following IVA with the TAE regimen for one year. The presence of ERM was associated with the metamorphopsia score.

Effect of Intravitreal Ranibizumab Injection on Different Optical Coherence Tomographic Patterns of Diabetic Macular Edema

Giriş ve Amaç: Spektral-domain optik koherens tomografi (SD-OKT) ile belirlenen farklı paternlerdeki diyabetik maküla ödemi (DMÖ) olgularında intravitreal ranibizumab (İVR) enjeksiyonunun erken dönem etkinliğini karşılaştırmak.&#x0D; Gereç ve Yöntemler: Tek doz İVR uygulanmış nonproliferatif diyabetik retinopatiye sekonder DMÖ olguları retrospektif olarak analiz edildi. Klinik anlamlı santral DMÖ’sü olan ve santral fovea kalınlığı (SFK)≥250 µm olan gözler çalışmaya dahil edildi. Olgular SD-OKT morfolojisine göre; süngerimsi diffüz retina kalınlaşması (DRK), kistoid maküla ödemi (KMÖ) ve seröz retina dekolmanı (SRD) gruplarına ayrıldı. Gruplar enjeksiyon öncesi ve enjeksiyon sonrası birinci ay kontrollerinde, en iyi düzeltilmiş görme keskinliği (EİDGK), SFK ve total maküla volümü (TMV) değişimi açısından karşılaştırıldı. SFK değişimi üzerindeki başlangıç SFK değerlerinin etkisini dışlamak için ANCOVA analizi ve gruplar arasında randomizasyon yapılarak alt analizler yapıldı. &#x0D; Bulgular: Çalışmaya 101 olgu (44 DRK, 40 KMÖ ve 17 SRD) dahil edildi. Gruplar yaş ve cinsiyet dağılımı açısından benzerdi (p&gt;0,05). Başlangıç EİDGK ve TMV değerleri arasında anlamlı fark yok iken (p&gt;0,05), başlangıç SFK değerleri büyükten küçüğe doğru sırası ile SRD, KMÖ ve DRK şeklinde sıralandı (p