scholarly journals Off-label use of bevacizumab for wet age-related macular degeneration in Europe

2019 ◽  
Vol 258 (3) ◽  
pp. 503-511
Author(s):  
Tomas Bro ◽  
Magdalena Derebecka ◽  
Øystein Kalsnes Jørstad ◽  
Andrzej Grzybowski
Keyword(s):  
Macular Degeneration ◽  
European Countries ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Governmental Institutions ◽  
Very High ◽  
Wet Amd ◽  
Label Use

Abstract Purpose To analyse current off-label use of bevacizumab for wet age-related macular degeneration (AMD) in Europe. Methods The study was conducted as a combined survey and literature review. It included the 22 most populous countries in Europe. In each country, ophthalmologists with particular knowledge about off-label treatment responded to a questionnaire. Results Answers were obtained from twenty European countries. The off-label use of bevacizumab for wet AMD greatly differed between nations; the bevacizumab proportion varied from non-existent (0%) to very high (97%). There were also large disparities within single countries (e.g. 0–80%), which were attributable to differences in regional decision-making. Both governmental institutions and national ophthalmological societies expressed highly diverging opinions on the use of off-label treatment. Intravitreal administration of bevacizumab had been a matter of legal dispute in several countries. The question about responsibility for off-label therapy mainly remained unanswered. Conclusions There was a highly varying utilization of bevacizumab between European countries. Despite an intention of a consistent approach to medical regulations, Europe has not yet reached a professional or political consensus on the ophthalmic off-label use of bevacizumab.

Off-Label Use of Bevacizumab for the Treatment of Age-Related Macular Degeneration

Drugs & Aging ◽  
2009 ◽  
Vol 26 (4) ◽  
pp. 295-320 ◽  
Author(s):  
Focke Ziemssen ◽  
Salvatore Grisanti ◽  
Karl Ulrich Bartz-Schmidt ◽  
Martin S. Spitzer
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Label Use

scholarly journals Off-Label Use of Bevacizumab in Age-Related Macular Degeneration: Protocol for a Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
João Estarreja ◽  
Carina Valente ◽  
Carina Silva ◽  
Pedro Camacho ◽  
Vanessa Mateus
Keyword(s):  
Systematic Review ◽  
Macular Degeneration ◽  
Vision Loss ◽  
Meta Analysis ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Pharmacological Approach ◽  
Age Related ◽  
Label Use

Abstract Background: Age-related macular degeneration (AMD) is considered the leading cause of vision loss in elderly people. Taking into account the phenomenon of aging worldwide, the prevalence of AMD is expected to increase gradually in the future. AMD can be divided into early, intermediate and late stages, where early and intermediate are mainly asymptomatic and, late-stage can be classified in non-vascular AMD and vascular AMD. Current pharmacological treatment in vascular AMD is associated with the administration of anti-VEGF agents, such as ranibizumab, pegaptanib, and aflibercept. Additionally, it has been reported the off-label use of bevacizumab, commonly associated with oncology, in this condition through intravitreal administrations, demonstrating efficacy allied with a lower cost in comparison to other agents used, which makes it a new possible pharmacological approach. In this sense, this review aims to evaluate the off-label use profile of bevacizumab in the treatment of neovascular AMD. Methods/design: To identify and select relevant articles present in current literature, it will be developed a highly sensitive search strategy. To develop this search, it will be used MEDLINE via the Pubmed platform. It will be only considered clinical studies, where it is compared the use of bevacizumab with another pharmacological agent, such as ranibizumab, or even a placebo, in patients aged 50 years and older, diagnosed with vascular AMD.Discussion: This review will provide a synthesis of the current information and underlying evidence, about the influence of the off-label use of bevacizumab in this disease. Altogether, it will allow having a clearer vision on a new possible accepted pharmacological approach for the treatment of vascular AMD.Systematic review registration: The protocol for this review will be submitted and registered with the International Prospective Register of Systematic Reviews (PROSPERO).

scholarly journals Outer retinal tubulation formation and clinical course of advanced age-related macular degeneration

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessandro Arrigo ◽  
Emanuela Aragona ◽  
Ottavia Battaglia ◽  
Andrea Saladino ◽  
Alessia Amato ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Müller Cells ◽  
Geographic Atrophy ◽  
Age Related Macular Degeneration ◽  
Advanced Age ◽  
Age Related ◽  
Dry Amd ◽  
Foveal Sparing ◽  
Wet Amd

AbstractOuter retinal tubulations (ORT) are a relatively new finding characterizing outer retinal atrophy. The main aim of the present study was to describe ORT development in advanced age-related macular degeneration (AMD) and to assess its relationship with disease’s severity. Patients with advanced AMD characterized either by macular neovascularization or geographic atrophy, showing signs of outer retinal disruption or retinal pigment epithelium atrophy on structural optical coherence tomography (OCT) at the inclusion examination were prospectively recruited. All the patients underwent complete ophthalmologic evaluation, structural OCT scans and fundus autofluorescence imaging. The planned follow-up was of 3-years. Main outcome measures were ORT prevalence, mechanism of ORT formation, mean time needed for complete ORT formation, best-corrected visual acuity (BCVA), definitely decreased autofluorescence (DDAF) area, questionably decreased autofluorescence (QDAF) area, retinal layer thickness, foveal sparing, number of intravitreal injections. We also assessed the possible role of external limiting membrane (ELM) and Müller cells in ORT pathogenesis. Seventy eyes (70 patients) were included; 43 showed dry AMD evolving to geographic atrophy, while 27 displayed the features of wet AMD. Baseline BCVA was 0.5 ± 0.5 LogMAR, decreasing to 0.9 ± 0.5 LogMAR at the 3-year follow-up (p < 0.01). We detected completely formed ORT in 26/70 eyes (37%), subdivided as follows: 20 eyes (77%) wet AMD and 6 eyes (23%) dry AMD (p < 0.01). ORT took 18 ± 8 months (range 3–35 months) to develop fully. We described the steps leading to ORT development, characterized by progressive involvement of, and damage to the photoreceptors, the ELM and the RPE. Eyes displaying ORT were associated with a smaller QDAF area, less retinal layers damage and lower rate of foveal sparing than eyes free of ORT (p < 0.01). We also described pigment accumulations simulating ORT, which were detected in 16/70 eyes (23%), associated with a greater loss of foveal sparing, increased DDAF area and smaller QDAF area at the 3-year follow-up (p < 0.01). In conclusion, this study provided a description of the steps leading to ORT development in AMD. ELM and Müller cells showed a role in ORT pathogenesis. Furthermore, we described a subtype of pigment hypertrophy mimicking ORT, evaluating its clinical utility.

scholarly journals Therapeutic Effect of Garcinia cambogia Extract and Hydroxycitric Acid Inhibiting Hypoxia-Inducible Factor in a Murine Model of Age-Related Macular Degeneration

2019 ◽  
Vol 20 (20) ◽  
pp. 5049 ◽  
Author(s):  
Ibuki ◽  
Shoda ◽  
Miwa ◽  
Ishida ◽  
Tsubota ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Hypoxia Inducible Factor ◽  
Age Related Macular Degeneration ◽  
Luciferase Assay ◽  
Inhibitory Effects ◽  
Garcinia Cambogia ◽  
Food Ingredients ◽  
Age Related ◽  
Dry Amd ◽  
Wet Amd

Background: Age-related macular degeneration (AMD) is the leading cause of blindness and can be classified into two types called atrophic AMD (dry AMD) and neovascular AMD (wet AMD). Dry AMD is characterized by cellular degeneration of the retinal pigment epithelium, choriocapillaris, and photoreceptors. Wet AMD is characterized by the invasion of abnormal vessels from the choroid. Although anti-vascular endothelial growth factor (VEGF) therapy has a potent therapeutic effect against the disease, there is a possibility of chorio-retinal atrophy and adverse systemic events due to long-term robust VEGF antagonism. We focused on hypoxia-inducible factor (HIF) regulation of VEGF transcription, and report the suppressive effects of HIF inhibition against ocular phenotypes in animal models. Many of the known HIF inhibitors are categorized as anti-cancer drugs, and their systemic side effects are cause for concern in clinical use. In this study, we explored food ingredients that have HIF inhibitory effects and verified their effects in an animal model of AMD. Methods: Food ingredients were screened using a luciferase assay. C57BL6/J mice were administered the Garcinia cambogia extract (Garcinia extract) and hydroxycitric acid (HCA). Choroidal neovascularization (CNV) was induced by laser irradiation. Results: Garcinia extract and HCA showed inhibitory effects on HIF in the luciferase assay. The laser CNV model mice showed significant reduction of CNV volume by administering Garcinia extract and HCA. Conclusions: Garcinia extract and HCA showed therapeutic effects in a murine AMD model.

scholarly journals Evaluation of Very High- and Very Low-Dose Intravitreal Aflibercept in Patients with Neovascular Age-Related Macular Degeneration

2012 ◽  
Vol 28 (6) ◽  
pp. 581-588 ◽  
Author(s):  
Quan Dong Nguyen ◽  
Peter A. Campochiaro ◽  
Syed Mahmood Shah ◽  
David J. Browning ◽  
Henry L. Hudson ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Low Dose ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Very High

scholarly journals Emerging Therapies for Wet-Form (Neovascular) Age-Related Macular Degeneration

2017 ◽  
pp. 235-240
Keyword(s):  
Macular Degeneration ◽  
Viral Vectors ◽  
Developed Countries ◽  
Age Related Macular Degeneration ◽  
Vegf Inhibitors ◽  
Anti Vegf ◽  
Age Related ◽  
Emerging Therapies ◽  
Endothelial Growth Factor ◽  
Wet Amd

Age-related macular degeneration (AMD) is the most common cause of permanent visual loss in persons over 65 years of age in developed countries. Currently, intravitreal vascular endothelial growth factor (VEGF) inhibitors are the mainstay of the treatment for patients with wet AMD. Despite significant improvements in visual acuity since the beginning of these therapies, challenges in the treatment of wet AMD are still present. Therefore, there are ongoing researches such as sustained-release anti-VEGF therapy, novel generation anti-VEGF agents, viral vectors to modify genetic transcription, and combination therapies. In this review, it is aimed to discuss these emerging therapies.

scholarly journals Choroidal thickness changes in age-related macular degeneration different forms and stages

2015 ◽  
Vol 8 (3) ◽  
pp. 13-19
Author(s):  
Svetlana Georgievna Belekhova ◽  
Yury Sergeevich Astakhov
Keyword(s):  
Macular Degeneration ◽  
Choroidal Thickness ◽  
Thickness Measurement ◽  
Healthy People ◽  
Age Related Macular Degeneration ◽  
Enhanced Depth Imaging ◽  
Depth Imaging ◽  
Age Related ◽  
Measurement Results ◽  
Wet Amd

Choroidal thickness measurement results of 124 patients (210 eyes) with age-related macular degeneration (AMD) obtained by enhanced depth imaging of spectral domain optical coherence tomography (EDI-OCT) are presented. There were no significant differences in choroidal thickness between patients with dry and wet AMD forms and healthy people of the same age group (р = 0.67; р = 0.26). A statistically significant choroidal thinning in patients with late AMD stages as compared to each of healthy people and dry and wet AMD patients was found (р < 0.0001).

scholarly journals Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study

2019 ◽  
Vol 4 (1) ◽  
pp. e000109 ◽  
Author(s):  
Michel Weber ◽  
Laurent Velasque ◽  
Florence Coscas ◽  
Céline Faure ◽  
Isabelle Aubry ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Safety Data ◽  
Age Related Macular Degeneration ◽  
Loading Dose ◽  
Clinical Practices ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
The Mean ◽  
Wet Amd

Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.

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