Comparison of ranibizumab efficacy in treatment-naive and previously treated patients with diabetic macular edema and evaluation of prognostic parameters

2021 ◽  
Vol 30 (3) ◽  
pp. 238
Author(s):  
Göksu Hande Naz Şimdivar ◽  
Selçuk Sızmaz ◽  
Ebru Esen ◽  
Ayşe Nihal Demircan
2020 ◽  
Vol 258 (3) ◽  
pp. 521-528 ◽  
Author(s):  
Jean-François Korobelnik ◽  
Vincent Daien ◽  
Céline Faure ◽  
Ramin Tadayoni ◽  
Audrey Giocanti-Auregan ◽  
...  

Abstract Purpose To report the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema (DME) in French clinical practice. Methods APOLLON (NCT02924311) was a prospective, observational cohort study of patients with DME. Effectiveness was evaluated by change from baseline in best-corrected visual acuity (BCVA) at 12 months in treatment-naïve patients (i.e., had not received any anti-vascular endothelial growth factor [anti-VEGF] agent, laser, or steroid at IVT-AFL treatment start) and previously treated patients (i.e., previously treated with anti-VEGF agents other than IVT-AFL, laser, or steroids at IVT-AFL treatment start). Secondary endpoints included change in central retinal thickness (CRT) over 12 months, frequency of injections, and proportion of patients with safety events. Results Of the 147 patients followed for at least 12 months and included in the effectiveness analysis, 52.4% (n = 77) were treatment-naïve and 47.6% (n = 70) were previously treated. Mean (standard deviation [SD]) BCVA score at baseline was 62.7 (14.3) Early Treatment Diabetic Retinopathy Study (ETDRS) letters in treatment-naïve patients and 60.0 (13.7) ETDRS letters in previously treated patients. At month 12, mean (SD) change in BCVA was + 7.8 (12.3) letters in treatment-naïve patients and + 5.0 (11.3) letters in previously treated patients. Mean CRT decreased in both patient cohorts. The mean (SD) number of IVT-AFL injections at month 12 was 7.6 (2.5) for treatment-naïve patients and 7.6 (2.3) for previously treated patients. Of 388 patients included in the safety analysis, ocular treatment-emergent adverse events occurred in 54.1% (n = 210) of patients. Conclusion IVT-AFL treatment was associated with improvements in functional and anatomic outcomes in both treatment-naïve and previously treated patients with DME in France.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Patricio J. Rodríguez-Valdés ◽  
Matus Rehak ◽  
Dinah Zur ◽  
Anna Sala-Puigdollers ◽  
Samantha Fraser-Bell ◽  
...  

AbstractTo analyze functional and anatomical response patterns to dexamethasone (DEX) implant in diabetic macular edema (DME), to describe proportion of responders and non-responders, and to propose a new DME grading system. Retrospective, multicenter, observational cohort study. Naïve and non-naïve DME patients were treated with DEX, with visual acuity (VA) ≥ 0.2 logMAR and central subfield thickness (CST) of ≥ 300 µm. Functional and anatomical responses were graded after 2 and 4 months, and categorized as early and stable improvement, early and progressive improvement, pendular response, delayed improvement, and persistent non-response. 417 eyes were included (175 treatment naïve eyes). Compared to non-naïve eyes, naïve eyes showed a very good functional response (VA gain ≥ 10 letters) more frequently after 2 and 4 months (56% and 57% [naïve] vs. 33% and 28% [non-naïve], p < 0.001). A VA gain < 5 letters (non-response) after 2 and 4 months was seen in 18% and 16% of naïve eyes, and in 49% and 53% of non-naïve eyes (p < 0.001). A lack of anatomical response was rare in both groups, but more frequently in non-naïve eyes (12% vs. 4%, p = 0.003). Functionally and anatomically, naïve eyes showed most frequently an early and stable improvement (functionally: 77/175 44%; anatomically: 123/175 eyes, 70%). Most non-naïve eyes experienced no significant improvement functionally (97/242 eyes, 40%), despite a mostly early and stable improvement anatomical response pattern (102/242 eyes, 42%). Functional but not anatomical response patterns were influenced by baseline VA. Naïve and non-naïve eyes show different functional and anatomical response patterns to DEX implant. Functional non-responders are rare in naïve eyes, whereas anatomical non-response is unusual in both groups.


2021 ◽  
pp. 112067212110294
Author(s):  
Ilkay Kilic Muftuoglu ◽  
Ecem Onder Tokuc ◽  
Fatma Sümer ◽  
V Levent Karabas

Purpose: To compare the efficacy of intravitreal (IV) ranibizumab (IVR) injection with IV dexamethasone implant (IVDEX) in treatment naive diabetic macular edema (DME) patients with inflammatory component. Materials and methods: Treatment naive DME eyes with subfoveal neurosensorial detachment (SND) and hyperreflective spots (HRS) were treated either three loading doses of IVR (18 eyes) or one dose of IVDEX (19 eyes). Central macular thickness (CMT), height of SND, the number of HRSs scattered on the individual retinal layers and photoreceptor integrity were assessed using spectral domain- optical coherence tomography scans over 3-months follow-up. Results: The mean change in best-corrected visual acuity (BCVA) was −0.11 ± 0.08 logMAR in IVDEX group and −0.04 ± 0.06 logMAR in IVR group at 1-month ( p = 0.011). IVDEX group showed statistically significant more increase in BCVA compared to those receiving IVR injections at 2-months ( p = 0.004) and 3-months ( p = 0.017) visits. Compared to baseline, the number of total HRSs and the number of HRSs at each individual inner retinal layer significantly decreased in both groups at all follow-up visits. However, IVDEX group showed more decrease in the total number of HRSs at 2- and 3-months ( p < 0.001 at 2-months, and p = 0.006 at 3-months) and in the mean number of HRSs located at inner nuclear layer–outer plexiform layer level ( p = 0.016 at 1-month, p < 0.001 at 2-months, and p < 0.001 at 3-months). After treatment, the number of HRSs on the outer nuclear layer showed some non-significant increase in both groups. Conclusion: HRSs tended to migrate from inner retina to the outer retina in DME eyes by treatment. Dexamethasone seemed to be more effective option in such cases with inflammatory component.


2021 ◽  
Vol 13 ◽  
pp. 251584142097911
Author(s):  
Diego Alejandro Valera-Cornejo ◽  
Marlon García-Roa ◽  
Jaime Quiroz-Mendoza ◽  
Alejandro Arias-Gómez ◽  
Paulina Ramírez-Neria ◽  
...  

Purpose: The purpose of the study is to describe visual and anatomic outcomes of 5774nm micropulse laser photocoagulation in eyes with either treatment-naïve or refractory diabetic macular edema (DME) at 3 months. Methods: This was a prospective case series that recruited 23 consecutive patients (33 eyes) with center-involved DME that was either treatment-naïve or had not responded to prior treatment. Micropulse therapy was performed with the Easy Ret 577 (Quantel Medical, Cournon d’Auvergne, France) diode laser in a high-density manner in eyes with treatment-naïve or refractory DME. The primary outcome was the change of best-corrected visual acuity (BCVA; logMAR) at 1 and 3 months. Secondary outcomes were changes in the central macular thickness (CMT), thickness area, macular volume, and macular capillary leakage at 1 and 3 months. Results: There were no significant changes in BCVA at 3 months, with mean ± standard deviation (SD) of −0.08 ± 0.01 ( p = 0.228) and + 0.01 ± 0.01 ( p = 0.969) for treatment-naïve and refractory groups, respectively. The change in CMT at 3 months was statistically but not clinically significant in the treatment-naïve group only (mean ± SD; –30 ± 130 µm; p = 0.011). The macular volume and area thickness change were not statistically significant ( p = 0.173 and p = 0.148 for macular volume and area thickness, respectively) in the treatment-naïve group. There was no difference concerning the leakage area in both groups. No adverse events were reported. Conclusion: We concluded that micropulse 577nm laser therapy maintained the visual acuity and macular thickness at 3 months in both treatment-naïve and refractory DME.


Author(s):  
Eileen Fonseca ◽  
David R Walker ◽  
Gregory P Hess

Background: Warfarin and dabigatran etexilate (DE) are oral anticoagulants (OAC) that reduce stroke risk among patients with nonvalvular atrial fibrillation (AF). However, DE does not require titration and INR monitoring. This study examined whether emergency department (ED) rate of admissions differed between the two therapies. Methods: Admission rate was evaluated for hospital encounters initiated in the ED, with a primary or secondary discharge diagnosis of AF between 1/1/2011-3/31/2012, with DE or warfarin administered during the encounter, and excluding encounters of valvular AF patients. Encounters were identified from a hospital Charge Detail Masters database containing 387 eligible hospitals. Samples were propensity score matched using nearest neighbor within a caliper of 0.20 standard deviations of the logit, without replacement, and a 2:1 match. Admission rates were estimated for encounters representing previously-treated patients and those representing treatment-naive patients using binominal generalized linear models, fitted by generalized estimating equations (clustered by hospital). Covariates estimating the propensity score and admission rate included age, payer type, use of bridging agents, AF as primary or secondary diagnosis, CHADS 2 and HAS-BLED scores, comorbid conditions, and hospital attributes. As a sensitivity analysis, admission rate was also estimated from the unmatched sample. Results: Matched samples included 2,688 warfarin and 1,344 DE ED encounters of previously-treated patients out of 15,053 and 1,367 ED encounters, respectively; and 2,578 warfarin and 1,289 DE ED encounters of OAC-treatment-naive patients out of 8,361 and 1,406 ED encounters, respectively. There were too few (n<5) matched encounters where the patient had prior OAC use but were new to the drug administered during the encounter, so these were excluded. No covariates used in matching had standardized mean differences > 10% after matching. Among the previously-treated sample, the estimated admission rate was 3.2% lower for DE compared to warfarin (88.3% vs. 91.5%, p=0.010) with sensitivity analysis confirming a lower admission rate for DE (91.1% vs. 93.8%, delta=2.7%, p=0.001). Among the treatment-naive sample, DE had a 1.2% lower admission rate compared to warfarin (95.2% vs. 96.3%, p=0.048). Sensitivity analysis confirmed a lower admission rate for DE (95.5% vs. 97.0%, delta=1.5%, p=0.001). Conclusions: While the vast majority of AF encounters initiated in the ED result in admission, encounters where patients were treated with DE as continuing or new therapy were less likely to be admitted compared to similar encounters where warfarin was administered.


2020 ◽  
pp. 112067212094976
Author(s):  
Dhanashree Ratra ◽  
Unnati Sharma ◽  
Daleena Dalan

Purpose: To evaluate the efficacy and safety of intravitreal dexamethasone implant in treatment naïve eyes with diabetic macular edema (DME). Methods: A retrospective analysis of treatment naïve eyes with DME which received intravitreal dexamethasone implant between January 2016 and March 2018 was done. Demographic details of the patients, ocular examination findings at baseline and on follow up visits were noted. Morphological features of DME and central macular thickness were noted on optical coherence tomography at each visit. The details regarding additional treatment for macular edema on follow up were noted. Results: Sixty five eyes were included in the study. The mean age was 59.14 ± 9.59 years. The follow up ranged from 6 to 48 months. Psuedophakic eyes showed visual improvement whereas the phakic eyes showed stable vision. The central foveal thickness showed significant reduction ( p = 0.05) in all the eyes. The best corrected visual acuity at final follow up (+0.65 logMAR) was slightly less as compared to baseline (+0.62 logMAR). Retreatment was needed in 37% eyes and antiglaucoma medications in 8% eyes. Cataract progression was noted in 24 eyes (37%); 17 eyes (26.1%) underwent surgery. Notably, 27 eyes (41.5%) had some degree of macular ischemia at baseline. And five eyes (7.7%) showed progression of retinopathy leading to vitreous hemorrhage. Conclusion: Dexamethasone implant is helpful in reducing the macular thickness and stabilizing the vision in treatment naïve DME; requiring less number of treatment sessions. However, it does not prevent progression of diabetic retinopathy. The visual improvement may be affected by cataract and macular ischemia.


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