scholarly journals Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Ugo Menchini ◽  
Francesco Bandello ◽  
Vincenzo De Angelis ◽  
Federico Ricci ◽  
Luigi Bonavia ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Italian Population ◽  
Open Label ◽  
Real World Evidence ◽  
Phase Iiib ◽  
Treatment Naïve ◽  
Prospective Phase ◽  
Cardiac Disorders ◽  
Pride Study

Purpose. An expanded access program (PRIDE study) in Italy to provide ranibizumab 0.5 mg to diabetic macular edema (DME) patients, prior to reimbursement.Methods. Open-label, prospective, phase IIIb study. Majority of patients were not treatment-naïve before enrollment. Patients received ranibizumab as per the EU label (2011). Safety was assessed by incidences of ocular/systemic adverse events (AEs) and serious AEs (SAEs) and efficacy in terms of visual acuity (VA) change from baseline (decimal score or Snellen (20/value)).Results. Overall, 515 patients (83.5%) completed the study. In unilateral/bilateral patients, commonly observed AEs were cardiac disorders (1.3%/1.3%) and nervous system disorders (1.3%/1.1%); SAEs were reported in 4.5%/4.8% of patients. Acute renal failure, lung carcinoma, and cardiac arrest were the causes of death in one unilateral and two bilateral patients. Ranibizumab improved/maintained VA (Snellen (20/value)/decimal scores) in both unilateral (up to −16.7/1.5) and bilateral patients (up to −23.6/1.2) at Month 5, with a mean of 4.15 and 4.40 injections, respectively. Overall, no difference was observed in the VA outcomes and treatment exposure between unilateral/bilateral patients.Conclusions. The PRIDE study provided early ranibizumab access to >600 Italian patients. Ranibizumab was well-tolerated and improved/maintained VA in 40.2%–68.8% patients, with no differences in case of unilateral or bilateral pathology. The study is registered with EudraCT.

RaScaL: A Pilot Study to Assess the Efficacy, Durability, and Safety of a Single Intervention with Ranibizumab plus Peripheral Laser for Diabetic Macular Edema Associated with Peripheral Nonperfusion on Ultrawide-Field Fluorescein Angiography

2014 ◽  
Vol 233 (2) ◽  
pp. 89-95 ◽  
Author(s):  
Ivan J. Suñer ◽  
Marc C. Peden ◽  
Mark E. Hammer ◽  
W. Sanderson Grizzard ◽  
Janet Traynom ◽  
...  
Keyword(s):  
Pilot Study ◽  
Fluorescein Angiography ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Treatment Naïve ◽  
Prospective Phase ◽  
Single Intervention

Background and Objectives: To determine the efficacy, durability, and safety of a single treatment with intravitreal ranibizumab plus peripheral scatter laser (RaScaL) in patients with diabetic macular edema associated with peripheral retinal nonperfusion on ultrawide-field fluorescein angiography (UWFA). Study Design: A 6-month, randomized, controlled, prospective phase I/II study of 30 treatment-naïve eyes of 22 patients (8 bilateral patients) with visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA. Patients were randomized to receive ranibizumab plus UWFA-guided peripheral scatter laser (n = 15) or triamcinolone acetonide plus macular laser (n = 15). Results: At 6 months, the RaScaL group patients had fewer recurrences warranting retreatment (33% vs. 80%, p < 0.003). Mean change in final visual acuity and central foveal thickness were not statistically significant between groups. Conclusion: This pilot study suggests the efficacy, safety and durability of the RaScaL treatment regimen in patients with diabetic macular edema associated with peripheral nonperfusion on UWFA.

scholarly journals Costs comparison of treating diabetic macular edema with aflibercept, ranibizumab or dexamethasone at 1 year in France (INVICOST study)

2021 ◽  
pp. 112067212110334
Author(s):  
Pierre Gascon ◽  
Isabelle Borget ◽  
Alban Comet ◽  
Laurence Carton ◽  
Frédéric Matonti ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Drug Acquisition ◽  
Cost Driver ◽  
Total Direct Cost ◽  
Open Label ◽  
Total Treatment Cost ◽  
Total Treatment ◽  
Treatment Naïve ◽  
The Difference

Purpose: INVICOST, a medico-economic analysis, compared costs of managing treatment-naive patients with diabetic macular edema (DME) receiving intravitreal injections (IVIs) of aflibercept (AFL), dexamethasone implant (DXI) or ranibizumab (RAN) over 1 year. Methods: Healthcare resource use and associated costs were estimated using individual patient data from INVICTUS, a prospective, open-label, monocentric study. Healthcare costs comprised direct medical costs such as drug acquisition and administration, consultations and ophthalmological procedures. Costs were assessed from the French National Health Insurance perspective using published national tariffs expressed in 2019 euros. Results: Of the 60 treated eyes, 48 had no treatment switch; 14 received AFL, 19 received DXI and 15 received RAN. AFL-treated eyes received an average of 6.5 IVIs, DXI-treated patients received 2 IVIs and RAN-treated received 6.8 IVIs. All treated eyes received an initial prescription for adjunctive ocular medications and 349 follow-up procedures were performed including an average of 3.9 optical coherence tomography and 3.2 retinography procedures per eye. Average total direct cost of per-eye treatment was €4516 (€1128–€8257). Average cost was €5782 for eyes treated with AFL, €2779 with DXI and €5536 with RAN. Drug therapy was the cost driver: €4394 (76%) for AFL, €1915 for DXI (69%) and €4268 (77%) for RAN. Conclusion: The difference in total treatment cost is largely explained by the significantly lower frequency of IVI and annual cost of therapy with DXI, compared with AFL and RAN. INVICOST is the first study comparing treatment costs with AFL, DXI and RAN in France in current clinical practice.

scholarly journals GRAding of functional and anatomical response to DExamethasone implant in patients with Diabetic Macular Edema: GRADE-DME Study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Patricio J. Rodríguez-Valdés ◽  
Matus Rehak ◽  
Dinah Zur ◽  
Anna Sala-Puigdollers ◽  
Samantha Fraser-Bell ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Response Pattern ◽  
Observational Cohort Study ◽  
Response Patterns ◽  
Dexamethasone Implant ◽  
Central Subfield Thickness ◽  
Treatment Naïve ◽  
Observational Cohort ◽  
Stable Improvement

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.

Evaluation of retinal inflammatory biomarkers after intravitreal steroid implant and Ranibizumab injection in diabetic macular edema

2021 ◽  
pp. 112067212110294
Author(s):  
Ilkay Kilic Muftuoglu ◽  
Ecem Onder Tokuc ◽  
Fatma Sümer ◽  
V Levent Karabas
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Outer Nuclear Layer ◽  
Plexiform Layer ◽  
Retinal Layer ◽  
Treatment Naïve ◽  
The Mean ◽  
The Individual ◽  
Inflammatory Component

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.

scholarly journals Micropulse laser in patients with refractory and treatment-naïve center–involved diabetic macular edema: short terms visual and anatomic outcomes

2021 ◽  
Vol 13 ◽  
pp. 251584142097911
Author(s):  
Diego Alejandro Valera-Cornejo ◽  
Marlon García-Roa ◽  
Jaime Quiroz-Mendoza ◽  
Alejandro Arias-Gómez ◽  
Paulina Ramírez-Neria ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Macular Thickness ◽  
Thickness Change ◽  
Macular Volume ◽  
Naive Group ◽  
Micropulse Laser ◽  
Refractory Diabetic Macular Edema ◽  
Treatment Naïve

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.

Efficacy and safety of intravitreal dexamethasone implant in treatment naïve eyes with diabetic macular edema: Real world experience

2020 ◽  
pp. 112067212094976
Author(s):  
Dhanashree Ratra ◽  
Unnati Sharma ◽  
Daleena Dalan
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Dexamethasone Implant ◽  
Efficacy And Safety ◽  
Visual Improvement ◽  
Intravitreal Dexamethasone Implant ◽  
Treatment Naïve ◽  
Intravitreal Dexamethasone ◽  
Macular Ischemia

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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