Individualized treat-and-extend regime for optimization of real-world vision outcome and improved patients’ persistence

Volkmann, Ingo; Knoll, Katharina; Wiezorrek, Mareile; Greb, Oliver; Framme, Carsten

doi:10.1186/s12886-020-01397-x

Cited by 20 publications

(20 citation statements)

References 36 publications

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“…Ideally, this approach would keep the macula continuously dry. Our own data using TE show results starting after the 1st injection that are also comparable to those of approval studies, while also showing subsequent high levels of patient adherence exceeding 90 % after 2 years [26]. It must be noted that a key factor in these results is performance of an OCT examination immediately prior to surgery, providing a basis for calculation of the time interval to be observed until the next injection.…”

Section: Introductionsupporting

confidence: 78%

Development of a Patient-Oriented Organizational Management System for Intravitreal Injection Therapy in a Standardized “Treat-and-Extend” Regime at a University Eye Clinic

Framme

Greb

Bayer³

et al. 2020

Klin Monbl Augenheilkd

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Background The treatment of macular edema with intravitreal injections has revolutionized the treatment of associated diseases in ophthalmology. However, with a few exceptions, this is a chronic treatment where patients require many injections and usually need to stay in treatment for years. Patient adherence and control of patient flow are critical to treatment success. In this manuscript, we describe the development of a patient-oriented organization management for intravitreal injections in a university hospital. Material and Methods In 2015, the intravitreal treatment in our clinic was switched to the treat-and-extend regime. At the same time, the optimization of the previous organizational processes in perioperative management was evaluated. For the period 2015 to 2018, we analyzed and gradually optimized the procedures of our intravitreal injection therapy in a survey with a specialized service provider. Results Through the analysis of the original processes, the patient appointment was optimized, work processes were summarized, spatially reorganized and there was only a slight increase in the number of staff involved compared with the significant increase in the number of injections. Through these measures, the total in-hospital-time of the patients could be drastically reduced and at the same time the number of patients on one operation day could be multiplied. Conclusion In the context of chronic treatment with intravitreal injections, the care of an increased number of patients is a logistical challenge. By optimizing processes, existing resources can be better used to meet the increased demands. An optimized system offers the patient greater adherence and a better visual outcome largely independent of the medication used.

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Section: Introductionsupporting

confidence: 78%

Development of a Patient-Oriented Organizational Management System for Intravitreal Injection Therapy in a Standardized “Treat-and-Extend” Regime at a University Eye Clinic

Framme

Greb

Bayer³

et al. 2020

Klin Monbl Augenheilkd

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“…In average, patients suffering from DME, AMD and RVO under either a pro re nata or a treat-and-extend antiangiogenic injection regime will require an average of 7 interventions during their first-year management. 28 , 29 This multiple exposition to the molecule implies not only the great importance of counting with the required evaluations to assure comparability and therefore no efficacy and safety differences between the biosimilar PRO-169 and the reference product, but also the relevance of having a biosimilar option that may relieve social and economic burden on patients who require multiple applications of the drug. There are several studies on the cost-effectiveness of this kinds of therapies, as well as the comparison between the commercially available options and how patients’ acquisitive power impacts their adherence to treatment.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab

Muñoz‐Villegas¹,

Sánchez‐Ríos²,

Quiñonez-Alvarado³

et al. 2021

JEP

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Background PRO-169 is a biosimilar candidate to bevacizumab (BEV), a monoclonal antibody (mAb) that inhibits vascular endothelial growth factor-A (VEGF-A) developed for intravitreal use. The current study demonstrates the intraocular pharmacokinetics (PK) of PRO-169 and its safety using New Zealand white (NZW) rabbits. Methods Intraocular concentration was evaluated in thirty-six rabbits at 1h, 1, 2, 5, 14 and 30 days after a single bilateral injection of PRO-169 or BEV (1.25 mg/0.05 mL). In a secondary experiment, safety was evaluated after three consecutive unilateral injections at 30-day intervals in twenty-four rabbits (PRO-169: 1.25 mg/0.05 mL or ranibizumab [RZB]: 0.5 mg/0.05 mL), by liver-associated enzymes (LAE), ophthalmological examination and adverse event (AE) incidence. Primary endpoints were vitreous maximum concentration (C max ), time to attain maximum concentration (t max ), area under curve (AUC 0-t ), half-life (t 1/2 ) and LAE. Secondary endpoints included aqueous humor (AH) and plasma pharmacokinetics, clinical examination and AEs. Results The C max in the vitreous was 593.75 ± 45.63 (PRO-169) vs 644.79 ± 62.65 µg/mL (BEV) (p= 0.136). T max was 0.53 ± 0.82 vs 0.85 ± 0.73 days (p= 0.330). The AUC 0-t was 3837.72 ± 465.91 vs 4247.31 ± 93.99 days*µg/mL (p= 0.052) and the half-life was 4.99 ± 0.89 vs 5.18 ± 0.88 days (p= 0.711). LAEs were normal in 92% of NZW rabbits; no differences between groups were observed (p>0.05). The AH and plasma PKs were also similar. Finally, clinical examinations found no alterations. AEs were observed in 25% of PRO-169 rabbits, without differences vs RZB (p=0.399). Conclusion PRO-169 can be efficiently diffused and distributed in ocular compartments, showing vitreous pharmacokinetics analogous to BEV. The safety experiment did not find evidence of clinical alterations from a repeated injection of PRO-169. These results provide scientific justification supporting that PRO-169 should be evaluated in future clinical trials to confirm its safety and efficacy.

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“…On the one hand, many patients may have been satisfied with both modalities and therefore do not prefer the one or the other; on the other hand, patients may trust in the opinion of their ophthalmologist and do not value the treatment strategy. A recent study underlines high persistence to therapy of patients treated with the T&E regimen over two years with good functional results [11]. To our knowledge there is no data published about patient's preference comparing PRN and T&E after having been treated with both therapy regimes.…”

Section: Discussionmentioning

confidence: 99%

Treatment contentment and preference of patients undergoing intravitreal anti-VEGF therapy

Kellner

Bedar

Weinitz

et al. 2021

Graefes Arch Clin Exp Ophthalmol

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The aim of this study is to investigate patients´ treatment preference between the pro re nata (PRN) and treat and extend (T&E) regimens and their feelings and contentment undergoing intravitreal injections (IVI) with anti-vascular endothelial growth factor (anti-VEGF) agents. Methods Six months after the switch of the treatment regimen from PRN to T&E, answers of a 16-item questionnaire of 105 patients under IVI therapy regarding age, sex and treatment preference (T&E or PRN regimen), as well as burden and anxiety resulting from therapy, were evaluated. Analysis of associations between answers of the questionnaire was executed using Pearson's Chi 2 test and Mann-Whitney U test. P values ≤ 0.05 were considered statistically significant. Results Nearly all patients (90.5%) felt well informed about disease and therapy. Comparing treatment regimen, 13.7% thought PRN was better and 23.3% felt T&E was better. The majority considered PRN and T&E to be equal (60.3%). No significant association between treatment regimen and age (p = 0.15), gender (p = 0.35) and duration of IVI therapy (p = 0.42) was seen. The examination results are associated with fear in the majority of patients (53.3%). Fear about the IVI was indicated by 47.6% of individuals and was significantly associated with pain during treatment (p = 0.0003), pain after treatment (p = 0.004) and fear about unfavourable examination results regarding disease activity (p = 7.94 × 10 −7 ). Conclusions Most patients are satisfied with the IVI therapy and the treatment regimen. Fear of the IVI and particularly of unfavourable examination results demonstrate the high treatment burden for patients undergoing anti-VEGF therapy. These aspects should be taken into account by healthcare professionals.

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Individualized treat-and-extend regime for optimization of real-world vision outcome and improved patients’ persistence

Cited by 20 publications

References 36 publications

Development of a Patient-Oriented Organizational Management System for Intravitreal Injection Therapy in a Standardized “Treat-and-Extend” Regime at a University Eye Clinic

Development of a Patient-Oriented Organizational Management System for Intravitreal Injection Therapy in a Standardized “Treat-and-Extend” Regime at a University Eye Clinic

Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab

Treatment contentment and preference of patients undergoing intravitreal anti-VEGF therapy

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