Resolution Of Diabetic Macular Edema Research Articles

Intravitreal conbercept injection with panretinal photocoagulation for high-risk proliferative diabetic retinopathy with vitreous hemorrhage

AIM: To assess the clinical efficacy and safety of combining panretinal photocoagulation (PRP) with intravitreal conbercept (IVC) injections for patients with high-risk proliferative diabetic retinopathy (HR-PDR) complicated by mild or moderate vitreous hemorrhage (VH), with or without diabetic macular edema (DME). METHODS: Patients diagnosed with VH with/without DME secondary to HR-PDR and received PRP combined with IVC injections were recruited in this retrospective study. Upon establishing the patient’s diagnosis, an initial IVC was performed, followed by prompt administration of PRP. In cases who significant bleeding persisted and impeded the laser operation, IVC was sustained before supplementing with PRP. Following the completion of PRP, patients were meticulously monitored for a minimum of six months. Laser therapy and IVC injections were judiciously adjusted based on fundus fluorescein angiography (FFA) results. Therapeutic effect and the incidence of adverse events were observed. RESULTS: Out of 42 patients (74 eyes), 29 were male and 13 were female, with a mean age of 59.17±12.74y (33-84y). The diabetic history was between 1wk and 26y, and the interval between the onset of visual symptoms and diagnosis of HR-PDR was 1wk-1y. The affected eye received 2.59±1.87 (1-10) IVC injections and underwent 5.5±1.02 (4-8) sessions of PRP. Of these, 68 eyes received PRP following 1 IVC injection, 5 eyes after 2 IVC injections, and 1 eye after 3 IVC injections. Complete absorption of VH was observed in all 74 eyes 5-50wk after initial treatment, with resolution of DME in 51 eyes 3-48wk after initial treatment. A newly developed epiretinal membrane was noted in one eye. Visual acuity significantly improved in 25 eyes. No complications such as glaucoma, retinal detachment, or endophthalmitis were reported. CONCLUSION: The study suggests that the combination of PRP with IVC injections is an effective and safe modality for treating diabetic VH in patients with HR-PDR.

Retinal OCT biomarkers associated with reading performance in patients with persistent vs. resolved diabetic macular edema.

Recent advancements in imaging technologies, particularly structural optical coherence tomography (OCT), have improved the understanding of diabetic macular edema (DME) pathophysiology and provided valuable biomarkers for disease progression and visual outcomes. This prospective study aimed to investigate the association between specific retinal biomarkers identified through OCT imaging and reading performance metrics in patients with previously treated persistent versus resolved DME and good visual acuity. Forty-nine eyes from 35 patients with a history of DME were enrolled. Reading performance was assessed using the Radner reading charts, which include standardized sentences with geometrically progressing print sizes. Structural alterations in the inner and outer retina, as well as the retinal pigment epithelium (RPE), were graded based on OCT images. Reading performance, measured as maximum reading speed, was associated with specific retinal biomarkers. The disruption of the ellipsoid zone (EZ) in the parafoveal region and the presence of disorganization of the inner retinal layers (DRIL) in the parafovea were correlated with reduced reading speed. These associations were independent of the presence of intraretinal or subretinal fluid. Understanding the relationship between retinal biomarkers and reading performance could contribute to a comprehensive evaluation of visual function and quality of life in patients with DME, leading to better management strategies and treatment outcomes.

Optical coherence tomography biomarkers indicating visual enhancement in diabetic macular edema resolved through anti-VEGF therapy: OCT biomarkers in resolved DME

Purposeto investigate the structural features and extended visual results in eyes affected by diabetic retinopathy (DR) and diabetic macular edema (DME) that have been successfully treated with anti-vascular endothelial growth factor (VEGF) therapy. MethodsIndividuals (39 eyes of 39 patients) who had undergone long-term follow-up and demonstrated evidence of resolved DME after at least 2 years of follow-up following the initiation of anti-VEGF therapy were included. During the ““study visit””, structural OCT scans were examined to assess qualitative features indicative of neuroretina or retinal pigment epithelium distress. Additionally, a quantitative assessment of the inner and outer retinal thicknesses was conducted for topographical analysis. ResultsThe most robust qualitative association observed with BCVA at the “study visit” was linked to the presence of DRIL (p = 0.043) and the appearance of the ELM. (p = 0.045). Regarding quantitative parameters, a strong correlation was noted between the visual acuity during the “study visit” and the foveal and parafoveal thicknesses of both the inner and outer retina (p < 0.001). ConclusionsChanges in the status of ELM, the presence of DRIL, and the thicknesses of the foveal and parafoveal regions can act as OCT biomarkers, signifying prolonged visual improvements in eyes that have experienced resolved DME after undergoing anti-VEGF therapy.

Biomarkers determining treatment interval of diabetic macular edema after initial resolution by anti-vascular endothelial growth factor.

To identify predictive factors that help determine the interval of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection after the initial resolution of diabetic macular edema (DME). This retrospective case-control study enrolled treatment-naïve DME patients who had achieved DME resolution after intravitreal anti-VEGF injections. Patients were classified into the recurrence and no-recurrence groups, depending on the development of recurrent DME after deferring intravitreal anti-VEGF injection. The demographics and clinical features, including optical coherence tomography findings, were compared between the two groups. We enrolled 105 eyes. Sixty eyes (57.1%) belonged to the no-recurrence group, and 45 (42.9%), belonged to the recurrence group. The severity of diabetic retinopathy at baseline was related to early DME recurrence (P = 0.009). At the treatment deferring point, the non-recurrence group had both thinner central subfield thickness (289.5 ± 27.2μm vs. 307.0 ± 38.2μm, P = 0.011) and thinner central retinal thickness (214.9 ± 41.4μm vs. 231.8 ± 41.2μm, P = 0.043) compared to the recurrence group. Intraretinal cyst was observed in 34 eyes (56.7%) in the no-recurrence group and 42 eyes (93.3%) in the recurrence group at the deferring point (P < 0.001). A low risk of early DME recurrence is anticipated in the eyes with foveal thinning and no intraretinal cyst when anti-VEGF injection is deferred. These predictive biomarkers can be useful for patient monitoring and determining treatment strategies for DME patients.

Cavitary Choroidal Nevus Showing Thickness Fluctuations in Response to Anti-VEGF Therapy for Diabetic Macular Edema: A Case Report.

To report the multimodal imaging features of a cavitary choroidal nevus showing thickness fluctuations that mirrored the response of diabetic macular edema (DME) to intravitreal anti-vascular endothelial growth factor (VEGF) therapy. Retrospective case report. Multimodal imaging findings including fundus photography, optical coherence tomography (OCT), fluorescein (FA) and indocyanine green angiography (ICGA), OCT-angiography (OCTA), and B-scan ultrasonography were analyzed. A female in her 80s with a cavitary choroidal nevus and DME was treated with intravitreal anti-VEGF therapy using a pro re nata regimen over 5 years. The choroidal nevus showed thickness fluctuations paralleling the response of DME to anti-VEGF therapy. Worsening of the DME was associated with marked increased choroidal lesion thickness on OCT. Conversely, resolution of DME after intravitreal anti-VEGF injections was followed by choroidal lesion flattening on OCT. Variations of the choroidal lesion thickness were mainly dependent on changes of intralesional hyporeflective caverns on OCT. Our report shows thickness variations of a cavitary choroidal nevus that paralleled the clinical course of DME treated with intravitreal anti-VEGF therapy. To the best of our knowledge, this is the first report on volume variations of a cavitary choroidal nevus following anti-VEGF therapy.

Prospective, Observational, Multicenter, Real-World Study of the Efficacy, Safety, and Pattern of Use of the Dexamethasone Intravitreal Implant in Diabetic Macular Edema in France: Short-Term Outcomes of LOUVRE 3.

To evaluate real-world efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in diabetic macular edema (DME) in France. In this prospective, multicenter, observational, noncomparative, post-reimbursement study, consecutively enrolled patients with DME had a baseline evaluation on day0. Those treated with DEX on day0 were to be reevaluated at week6 and months6, 12, 18, and 24. DEX retreatment and/or alternative therapies were allowed during follow-up. The primary outcome measure was themaximum best corrected visual acuity (BCVA) gain from baseline during follow-up. Secondary outcome measures included time to maximum BCVA gain, patients (%) with prespecified BCVA gains from baseline at each visit, maximum central retinal thickness (CRT) reduction from baseline, patients (%) with CRT reduction ≥ 20% from baseline at each visit, patients (%) with DME resolution (per investigator judgement), and adverse events (AEs). Of 112 patients/eyes with DME for 3.5years (mean) at baseline, 80 (including 86.1% previously treated) received DEX on day0 and were analyzed for efficacy. Early study termination precluded collection of ≥ 12-month efficacy data. Patients received 1.4 DEX injections over 8.3months (averages). The maximum BCVA gain from baseline was 3.6 letters, reached after 77.2days (averages); 24.6% (week6) and 15.0% (month6) of patients experienced ≥ 10-letter BCVA gains from baseline. The mean maximum CRT reduction from baseline was -146.4µm; 61.4% (week6) and 36.0% (month6) of patients had CRT reductions ≥ 20% from baseline, and 68.1% reported DME resolution at least once during follow-up. Ocular hypertension (n = 8, 12.1%) was the most frequent treatment-related AE. LOUVRE 3 confirmed that DEX improves BCVA andCRT, even in a patient population that had predominantly received DEX before enrollment in the study, and showed that DME resolution was observed during follow-up. DEX tolerability was consistent with published data, supporting treatment benefits in DME. NCT03003416.

Imaging biomarkers and clinical factors associated with the rate of progressive inner and outer retinal thinning in patients with diabetic macular edema

The aim of this study was to assess the relationship of clinical characteristics to the rate of retinal thinning in eyes with diabetic macular edema (DME) treated with anti-vascular endothelial growth factor (VEGF) therapy. We analyzed subjects with a long-term follow-up (≥ 3 years) and evidence of resolved DME after the initiation of anti-VEGF therapy (baseline visit). To measure the long-term rate of retinal thinning during treatment, a second visit (first visit with evidence of resolved DME after 3 years) was also considered. A longitudinal quantitative topographical assessment of the inner and outer retinal thicknesses was provided. Clinical characteristics were associated with the rate of longitudinal retinal thinning. We included 56 eyes (50 patients) in the analysis. A significant longitudinal thinning in the inner and outer retina was detected in all the analyzed regions (p values between 0.027 and < 0.0001). In the multivariable analysis, type of diabetes (type 2 vs. type 1) was associated with increased foveal inner retinal thinning (p = 0.019). A higher number of subfoveal neuroretinal detachment during follow-up (p = 0.006) was associated with faster rates of foveal outer retinal thinning. Type of diabetes (p < 0.0001), higher age (p = 0.033) and cystoid macular edema phenotype (p = 0.040) were associated with increased parafoveal inner retinal thinning. Gender (p = 0.003) and diabetic retinopathy stage (p = 0.013) were associated with faster rates of perifoveal inner retinal thinning, while diabetic retinopathy stage (p = 0.036) was associated with increased perifoveal outer retinal thinning. In conclusion, clinical factors, including DME phenotypes, were associated with the rates of retinal thinning in patients undergoing anti-VEGF treatment.

Baseline Diabetic Retinopathy Severity and Time to Diabetic Macular Edema Resolution with Ranibizumab Treatment: A Meta-Analysis

Having a better understanding of how long diabetic macular edema (DME) takes to resolve in patients with diabetic retinopathy (DR) after treatment with ranibizumab, and the factors affecting this outcome, would be of benefit to physicians and patients alike. The objective of this analysis was to evaluate the time to first DME resolution and the impact of baseline DR severity on this outcome in patients treated with ranibizumab in phase III clinical trials. Meta-analysis of data from the phase III trials, RIDE (NCT00473382) and RISE (NCT00473330), and DR Clinical Research Network protocols I (NCT00444600), S (NCT01489189), and T (NCT01627249). Patients with DME (central subfield thickness [CST] > 250 μm) and DR with Diabetic Retinopathy Severity Scale (DRSS) score between 35 and85. Intravitreal injection of ranibizumab. The time to first DME resolution (defined as CST ≤ 250 μm) within 24 months was evaluated overall and by baseline DR severity category per the DRSS (35 of 43 [mild or moderate nonproliferative DR], 47-53 [moderately severe or severe nonproliferative DR], 60 [mild proliferative DR], and 61-85 [moderately severe to severe proliferative DR]). There were 777 patients included in the meta-analysis. The overall mean (95% confidence interval) time to first DME resolution, adjusted for baseline CST, was 6.0 (5.6-6.4) months. The mean (95% CI) time to first DME resolution was 7.1 (6.2-7.9), 5.9 (5.2-6.6), 6.0 (4.8-7.2), and 4.5 (3.5-5.5) months for the 35 of 43, 47 to 53, 60, and 61 to 85 baseline DRSS categories, respectively (overall P= 0.002). By month 24, the proportion of eyes with DME resolution was 74.9% (221 of 295), 77.5% (299 of 386), 69.4% (109 of 157), and 78.7% (148 of 188) for the 35 of 43, 47 to 53, 60, and 61 to 85 baseline DRSS categories, respectively (overall P= 0.17). This meta-analysis of data from patients treated with ranibizumab showed that DME resolution was faster in patients with more severe DR at baseline. However, by month 24, a similar proportion of patients achieved DME resolution, regardless of baseline DR severity. These findings may guide treatment decisions and inform patient expectations in clinical practice. Proprietary or commercial disclosure may be found after the references.

Ayurvedic Management of Diabetic Macular Oedema — DME (&lt;i&gt;Sannipataja timira&lt;/i&gt;) — A Case Report

Background: Diabetic Macular Edema (DME) is the primary cause of visual loss in Diabetic Retinopathy (DR). The hyperglycemic state promotes the activation of multiple interlinked pathways leading to DME. The current guidelines in contemporary science recommend Anti VEG-F injections as the first line of treatment for this condition. Repeated Anti-VEG-F injections cause much financial burden on the patient and their family, at the cost of minimal visual outcome. From the signs and symptoms, it was diagnosed as Sannipataja timira according to Ayurveda. A 53-year-old male patient sought Ayurvedic treatment when his vision in the right eye did not improve after the injection of Accentrix for DME. His ophthalmologist advised him to repeat the injection after six months but did not assure him of complete resolution of edema. So, he opted for Ayurvedic treatment. His treatment comprised internal medicines consisting of Punarnavadi kashaya, Guduchyadi kashaya, Chandraprabha vati, Gomutra haritaki lehya; external treatments like Talpodichil with Punarnavadi churna and Pratimarsha nasya with Anu taila; Kriyakalpas (eye treatments) like Vidalaka and Anjana karma. At the end of 7.5 months of Ayurvedic treatment, his visual acuity improved from 6/60 to 6/6. Optical Coherence Tomography (OCT) affirmed the full resolution of DME. Ayurvedic treatment effectively reversed the process of macular edema, thereby bringing about marked visual outcomes in DME. Such patients shall be encouraged to go for Ayurvedic treatments, not the expensive and invasive Anti-VEGF injections.

Time to Resolution of Diabetic Macular Edema after Treatment with Intravitreal Aflibercept Injection or Laser in VISTA and VIVID

To assess the relationship between baseline factors and time to diabetic macular edema (DME) resolution. Post hoc analysis of VISTA and VIVID. Eyes with baseline central subfield thickness (CST) of ≥ 290 μm. Eyes were treated with intravitreal aflibercept injection (IAI) 2 mg (n= 558; every 4 weeks or every 8 weeks after 5 monthly doses) or laser control (n= 274). The effect of baseline factors on the time to DME resolution (CST < 290 μm) was assessed in univariable and multivariable models and further evaluated by the Kaplan-Meier method. Time to and cumulative incidence of DME resolution. Eyes treated with IAI had a 2.5-fold higher DME resolution rate, with median time of 33.0 weeks (95% confidence interval [CI], 28.1-40.0), compared with DME resolution not being achieved in 50% of eyes treated with laser control. Multivariable analysis demonstrated that a lower DME resolution rate was associated with a thicker baseline CST (hazard ratio [HR] [95% CI] per 100-μm CST increase, 0.79 [0.72-0.86]) and better baseline best-corrected visual acuity (BCVA) (HR [95% CI] per 5-letter increase, 0.87 [0.83-0.92]) with IAI. Tertiles of increasing CST (T1CST ≤ 419 μm; T2CST > 419 to ≤ 541; T3CST > 541) were associated with longer median times to DME resolution (20.1, 39.1, and 49.1 weeks, respectively; P < 0.001 for T2CST and T3CST versus T1CST) and lower cumulative incidence of events (HR, 1.0, 0.6, and 0.6, respectively; P < 0.001 for T2CST and T3CST versus T1CST) with IAI. Tertiles of increasing BCVA (T1BCVA ≤ 57 letters; T2BCVA > 57 to ≤ 66; T3BCVA >66) were associated with longer median times to DME resolution (28.4, 31.7, and 44.1 weeks, respectively; P < 0.05 for T3BCVA versus T1BCVA) and lower cumulative incidence of events (HR, 1.0, 0.9, and 0.8, respectively; P < 0.05 for T3BCVA versus T1BCVA) with IAI. No other baseline factor was associated with the time to DME resolution. The median time to DME resolution was 33 weeks among IAI-treated eyes. A thicker baseline CST and better baseline BCVA in the IAI group were associated with a longer time to and a lower rate of DME resolution.

Factors Associated With the Presence of Foveal Bulge in Eyes With Resolved Diabetic Macular Edema.

Purpose: To evaluate factors associated with the presence of foveal bulge (FB) in resolved diabetic macular edema (DME) eyes.Methods: A total of 165 eyes with complete integrity of ellipsoid zone (EZ) at the fovea and resolved DME were divided into two groups according to the presence of FB at 6 months after intravitreal injection of ranibizumab treatment. Best-corrected visual acuity (BCVA), central foveal thickness (CFT), outer nuclear layer (ONL) thickness, height of serous retinal detachment (SRD) and non-SRD, and inner segment (IS) and outer segment (OS) lengths of the two groups were measured and compared at baseline and each follow-up. The correlations between the presence of FB and pre- and post-treatment factors were determined by logistic regression analysis.Results: At baseline, BCVA was significantly better, and CFT and incidence and height of SRD were significantly lower in the FB (+) group (all P < 0.05). At 6 months, FB was present in 65 (39.39%) eyes. Post-treatment BCVA was significantly better and OS length was significantly longer in the FB (+) group at 6 months (all P < 0.05). Multivariate analysis identified younger age, better BCVA, and lower CFT before treatment as significant predictors of the existence of FB at 6 months (all P < 0.05). At 6 months, better BCVA and longer OS length were significantly correlated with the existence of FB (all P < 0.05).Conclusions: Factors associated with the presence of FB after the resolution of DME include younger age, better baseline BCVA and lower baseline CFT, and better post-treatment BCVA and longer post-treatment OS length.

Long-Term Visual Outcomes and Morphologic Biomarkers of Vision Loss in Eyes With Diabetic Macular Edema Treated With Anti-VEGF Therapy

To analyze the morphological characteristics and long-term visual outcomes in eyes with diabetic retinopathy (DR) and diabetic macular edema (DME) treated with anti-vascular endothelial growth factor (anti-VEGF) therapy. Retrospective clinical cohort study. Patients with a long-term follow-up and evidence of resolved DME in at least 1 visit (study visit) after 5 years of follow-up after the initiation of anti-VEGF therapy were included. At the study visit, structural optical coherence tomography (OCT) scans were reviewed for qualitative features reflecting a distress of the neuroretina or retinal pigment epithelium (RPE). A quantitative topographical assessment of the inner and outer retinal thicknesses was also provided. A total of 61 eyes (50 patients) were included and were divided into 2 subgroups according to visual acuity (VA) at the study visit, yielding a group of 24 eyes with a VA <20/40 ("poor/intermediate vision" group), and 37 eyes with a VA ≥20/40 ("good vision" group). The external limiting membrane (ELM) and RPE bands were more frequently disrupted or absent in the poor/intermediate vision group (P=.003 and P=.019). Similarly, disorganization of retinal inner layers was more prevalent in the poor/intermediate vision group (P=.013). The foveal and parafoveal outer retinal thicknesses were reduced in eyes with poor/intermediate vision (P=.022 and P=.044). Multivariate stepwise linear regression analysis demonstrated that VA was associated with appearances of the RPE and ELM (P < .0001 and P=.048), foveal and parafoveal outer retinal thicknesses (P=.046 and P=.035). Modifications in the outer retina and RPE represent OCT biomarkers of long-term visual outcomes in eyes with DME treated with anti-VEGF.

Retinal Sensitivity and Structural Changes after Focal Photocoagulation for Diabetic Macular Edema: A Multisectorial Comparison

Introduction: The hindrance of a macular laser treatment for diabetic macular edema (DME) remains unclear. Our purpose was to evaluate macular functional and structural changes after focal macular photocoagulation for DME. Methods: This is a prospective cohort study that included patients with mild diabetic retinopathy, submitted to focal macular laser treatment as monotherapy for DME. Patients underwent optical coherence tomography and microperimetry after the necessary number of treatment sessions for complete resolution of DME. Eyes were compared in each macular sector (superior, temporal, and inferior 1- to 3-mm parafoveal ring) according to the presence of laser spots. Relative sensitivity was calculated as sectorial sensitivity divided by general sensitivity. Results: Sixty-four eyes were included. In sectors submitted to focal photocoagulation, we observed a significant reduction in absolute sensitivity (−1.0 to −0.4 dB, depending on the sector analyzed) and relative sensitivity (−2.1 to −0.6%) together with a reduction in the outer nuclear layer (ONL) thickness (−8 to −3 μm). The number of laser spots correlated with both functional and structural changes. Conclusion: In macular sectors that underwent photocoagulation, we found a small reduction in retinal sensitivity together with a reduction in the corresponding ONL thickness.

Time Of Maximum Resolution Of Diabetic Macular Oedema After Ranibizumab Injection

Macular edema is defined as an abnormal thickening of the macula associated with the accumulation of excess fluid in the extracellular space of the neurosensory retina. Intracellular edema involving Muller cells has also been observed histopathologically in some cases. DME results from retinal microvascular changes, thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the BRB leads toleakage of plasma constituents into the surrounding retina, with subsequent retinal edema. Hypoxia induced by this mechanism can also stimulate VEGF production. There is evidence that VEGF is up-regulated in DME and proliferative diabetic retinopathy. Ranibizumab was approved by the FDA in June 2006 for the treatment of all subtypes of neovascular AMD and was approved in 2010 for the treatment of macular edema associated with retinal vein occlusion and diabetic retinopathy.Optical coherence tomography is a non-invasive diagnostic method for the high-resolution imaging of ocular tissues. OCT is very helpful in the diagnosis and follow-up of DME,and OCT also analyzes the vitreomacular relationship.

Evaluation of vessel density in disorganization of retinal inner layers after resolved diabetic macular edema using optical coherence tomography angiography.

PurposeTo evaluate the retinal vessel density (VD) in the macular region and the foveal avascular zone (FAZ) area using optical coherence tomography angiography (OCTA) in patients with and without disorganization of retinal inner layers (DRILs) after resolution of diabetic macular edema.MethodsThirty-seven eyes of 37 DRIL patients (mean age 63 ± 13.97 years), 30 eyes of 30 no DRIL patients and 35 eyes of 35 controls were enrolled in this study. We evaluated the VD in the macular region of superficial capillary plexus (SCP), deep capillary plexus (DCP) and FAZ area.ResultsDRIL and no DRIL groups showed decreased VD in SCP and DCP (p<0.05) and a larger FAZ area (p<0.001) compared to controls. However, DRIL patients revealed a statistically significant reduction in VD of SCP (p = 0.041) and a greater FAZ area (p<0.001) with respect to no DRIL patients. We found a significant negative correlation between the VD of the foveal SCP (r = -0.414, p = 0.011), foveal DCP (r = -0.358, p = 0.025) and best corrected visual acuity (BCVA) in DRIL group. Moreover there was a significant positive correlation between the FAZ area (r = 0.425, p = 0.034) and BCVA. Therefore, in presence of DRILs lower VD values of SCP and DCP and a larger FAZ area correlated with a worse visual acuity. In no DRILs group, there was a significant negative correlation between the VD of the foveal DCP and BCVA.ConclusionOCTA highlights the role of retinal vascular ischemia in the pathogenesis of DRILs. This parameter could represent an important functional predictive factor in diabetic patients.

Optical Coherence Tomography Biomarkers: Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19-mg Fluocinolone Acetonide Implant

Background: The 0.19-mg fluocinolone acetonide (FAc) implant (ILUVIEN^®; Alimera Sciences Ltd., Hampshire, UK) was approved for the treatment of vision impairment associated with chronic and refractory diabetic macular edema (DME). Objectives: To quantitatively assess functional and structural features in nonvitrectomized and vitrectomized DME patients after being treated with an FAc implant. Methods: Retrospective review of patients with DME receiving a single intravitreal injection of the FAc implant. The study was designed to analyze the presence of quantitative structural OCT biomarkers at baseline and 12 months after FAc therapy according to vitreous status. Results: A total of 41 eyes from 30 patients were included in this study. At 12 months after injection, vitrectomized patients had a lower central foveal thickness (p = 0.017) and fewer hyperreflective dots (p = 0.028) compared with nonvitrectomized. Thirty (73%) patients presented a significant functional improvement with 17 (42%) increasing at least 15 ETDRS letters. Overall, 22 (54%) eyes had a complete resolution of DME at the 12-month visit. Patients who needed additional therapy had a higher prevalence of subretinal fluid (42 vs. 3%, p = 0.005) at baseline. Conclusions: This study supports the effectiveness of the FAc implant and reports significant changes at 12 months after FAc injection.

Cost-consequence analysis of extended loading dose of anti-VEGF treatment in diabetic macular edema patients

BackgroundThe DRCR.net Protocol T clinical trial assessed the comparative efficacy and safety of anti-VEGF treatments including aflibercept, ranibizumab and bevacizumab in diabetic macular edema (DME). Post -hoc analyses showed that after a 12-week induction period, there was still DME resolution in an increasing number of patients through week 24.PurposeTo assess clinical and cost consequences of extending the anti-VEGF loading dose from 3 to 6 monthly injections in patients with persistent DME in Spain.MethodsFrom a hospital pharmacy perspective, a cost-consequence analysis model was developed to estimate the incremental cost needed to obtain an additional response at month 6. To estimate drug treatment costs, ex-factory prices (€, 2019) were considered for aflibercept, ranibizumab and bevacizumab. Response/nonresponse rates at 3/6 months were obtained from the Protocol T 24-week post hoc analysis (n = 546). Persistent DME was present in 50.8 and 31.6% of the 190 aflibercept-treated patients at month 3 and month 6, respectively. Of the 176 ranibizumab- and 180 bevacizumab-treated patients, 53.2 and 72.9%, respectively, had persistent DME at month 3, and 41.5 and 65.6%, respectively, had persistent DME at month 6. Sensitivity analysis considered the split of bevacizumab vials.ResultsExtending the loading dose in nonresponder patients would cost €214,862.57, €208,488.98 and €134,483.16 to obtain 37, 21 and 13 additional aflibercept, ranibizumab and bevacizumab responder patients, respectively. The total number of extended injections (months 3–6) used in patients with persistent DME at month 6 was 180, 219 and 354 for aflibercept, ranibizumab and bevacizumab, respectively.ConclusionsTo extend the anti-VEGF loading dose from 3 to 6 injections necessitates investing €5882.77 (8 injections), €10,091.03 (14 injections) and €10,198.59 (30 injections) per additional responder patient (3-month nonresponders and 6-month responders) to aflibercept, ranibizumab and bevacizumab, respectively. For the total of patients treated, on average €7927.02 (14 injections) per additional responder patient would be needed.

Twenty-Four-Month OCTA Assessment in Diabetic Patients Undergoing Fixed-Interval Intravitreal Aflibercept Therapy.

Evaluate capillary perfusion density (CPD) in patients with diabetic macular edema (DME) undergoing fixed intravit-real aflibercept injections (IAI) through 24 months. Prospective, interventional, single-arm study enrolling 20 patients with persistent DME. Patients received IAI every 4 weeks until DME resolution followed by extension to every 8 weeks. Optical coherence tomography angiography was obtained at baseline, 6, 12, and 24 months. Sixteen of 20 eyes completed the study. Baseline mean central subfield thickness was 420 µm, which improved to 251 µm (P < .001). The mean best-corrected visual acuity (BCVA) improved by 5.5 letters (P = .042). The whole superficial CPD decreased by 5.3% (P = .001) and the deep CPD decreased by 4.4% (P = .009). Better BCVA correlated with less CPD loss within the superficial parafovea (r = +0.66 [0.23, 0.88]; P = .006) and whole (r = +0.60 [0.12, 0.85]; P = .017) areas. Superficial and deep CPD decreased despite fixed IAI through 24 months. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:448-455.].

Restoration of Foveal Bulge after Resolution of Diabetic Macular Edema with Coexisting Serous Retinal Detachment.

Purpose To evaluate the impact of restoration of foveal bulge (FB) in optical coherence tomography (OCT) images on visual acuity after resolution of diabetic macular edema with coexisting serous retinal detachment (SRD-DME). Methods A total of 52 eyes with resolved SRD-DME and an intact ellipsoid zone at the central fovea were included. All eyes underwent best-corrected visual acuity (BCVA) examination and OCT scanning at baseline and follow-up visits (1, 3, and 6 months). The eyes were divided into two groups according to the presence of FB at 6 months. BCVA, central foveal thickness (CFT), height of SRD (SRDH), outer nuclear layer (ONL) thickness, photoreceptor inner segment (PIS), and outer segment (POS) length were compared between the two groups. Results A FB was found in 25 of 52 (48%) eyes at 6 months. The FB (+) group had lower SRDH at baseline, and better BCVA, longer POS length at 6 months (all P < 0.05). There was no significant difference in the CFT, ONL thickness, and PIS length at 6 months between the two groups (all P > 0.05). More eyes in the FB (+) group had complete SRD resolution at 1 month (P = 0.009) and 3 months (P = 0.012). Eyes with complete SRD resolution at 1 month (P = 0.009) or 3 months (P = 0.012) were more likely to have a FB at 6 months. Conclusions The Presence of the FB is associated with better BCVA after resolution of SRD-DME. Eyes with lower baseline SRDH or faster SRD resolution are more likely to have a FB at 6 months.

Comparison of Retinal Layer Thickness in Eyes with Resolved Diabetic Macular Edema Receiving Ranibizumab with Normal Eyes

Purpose: To evaluate the thickness of individual retinal layers in eyes with resolved diabetic macular edema (DME) after treatment with ranibizumab (RBZ). Methods: Spectral-domain optical coherence tomography (OCT) scans of 25 eyes (25 patients) with DME that had been treated with RBZ (and shown resolution of edema as evident by the absence of fluid in a high-resolution grid placed on the fovea) were acquired using Spectralis HRA + OCT^TM. Thickness measurements of individual layers were calculated using papillomacular bundle (PMB), central subfield, and inner- and outer-ring Early Treatment Diabetic Retinopathy Study (ETDRS) grids. Measurements were compared to 45 normal eyes with no known retinal disease. A post-hoc analysis was done correlating visual acuity (VA) with individual retinal layer thickness. Results: Full retinal thickness (FRT) was thinner than normal individuals across all 4 grids. There were similarities and differences among the 4 grids; however, PMB and inner-ring ETDRS grids displayed the most resemblance. The VA significantly correlated with the FRT measured in PMB (p = 0.004), central subfield (p = 0.02), and inner-ring (p = 0.006) ETDRS. Conclusions: Segmentation of OCT scans revealed significant differences in the overall thickness of the retina and of individual retinal layers in patients with resolved DME. PMB grid showed a stronger correlation between affected retinal layers and VA compared to ETDRS. PMB also showed significance with VA in layers that were shown to be not significant in ETDRS grid.