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Age-Related Macular Degeneration

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1. Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema

Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema 1 Translation of the key statement of the final report D15-01 Optische Kohärenztomografie bei neovaskulärer altersbedingter Makuladegeneration sowie beim Makulaödem im Rahmen der diabetischen Retinopathie (Version 1.1; Status: 7 July 2017). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English (...) -language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. D15-01 Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema 1 Extract of final report D15-01 Version 1.1 Optical coherence tomography for maculo- and retinopathy 7 July 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

2. Age-related macular degeneration

Age-related macular degeneration Age-related macular degener Age-related macular degeneration ation NICE guideline Published: 23 January 2018 nice.org.uk/guidance/ng82 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising (...) . Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Age-related macular degeneration (NG82) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 24Contents Contents Overview 4 Who is it for? 4 Recommendations 5 1.1 Classifying age-related macular

2018 National Institute for Health and Clinical Excellence - Clinical Guidelines

3. Brolucizumab–dbll (Beovu) - wet age-related macular degeneration

Brolucizumab–dbll (Beovu) - wet age-related macular degeneration CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761125Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S) 1 Office of Clinical Pharmacology Review BLA Number 761125 Link to EDR Link Submission Date 02/07/2019 Submission Type Priority Proposed Brand Name Beovu Generic Name Brolucizumab (RTH258) Dosage Form and Strength 120 mg/mL solution for intravitreal injection Route of Administration Local Proposed Indication Treatment (...) of neovascular age-related macular degeneration (AMD) Applicant Novartis Pharmaceuticals Corporation Associated IND IND 112023 OCP Review Team Abhay Joshi, Ph.D. Philip Colangelo, Pharm.D., Ph.D. OCP Final Signatory John A. Lazor, Pharm.D. Office of Clinical Pharmacology Division IV Director Reference ID: 44719932 Table of Contents Table of Contents 2 1. EXECUTIVE SUMMARY 3 1.1 Recommendations 3 1.2 Post-Marketing Requirements and Commitments 4 2. SUMMARY OF CLINICAL PHARMACOLOGY ASSESSMENT 4 2.1

2019 FDA - Drug Approval Package

4. Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD)

Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD) Dec2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 EUnetHTA Joint Action 3 WP4 Version 1.0, 12/03/2020 Relative effectiveness assessment of pharmaceutical technologies BROLUCIZUMAB FOR THE TREATMENT OF ADULTS WITH NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (AMD) Project ID: PTJA09 PTJA09 - Brolucizumab for patients with neovascular (wet (...) with neovascular (wet) age-related macular degeneration (AMD). Joint Assessment. Diemen (The Netherlands): EUnetHTA; 2020. [date of citation]. 124 pages. Report No.: PTJA09. Available from: https //www.eunethta.eu PTJA09 - Brolucizumab for patients with neovascular (wet) AMD March 2020 EUnetHTA Joint Action 3 WP4 3 TABLE OF CONTENTS DOCUMENT HISTORY AND CONTRIBUTORS 1 TABLE OF CONTENTS 3 LIST OF TABLES AND FIGURES 5 LIST OF ABBREVIATIONS 8 EXECUTIVE SUMMARY OF THE ASSESSMENT OF BROLUCIZUMAB 10 INTRODUCTION 10

2020 EUnetHTA

5. Age-related macular degeneration

Age-related macular degeneration Age-related macular degeneration - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Age-related macular degeneration Last reviewed: February 2019 Last updated: May 2018 Summary Potentially progressive maculopathy. Sudden-onset of blurring or distortion of vision is often the presenting symptom. Characterised by drusen formation, macular pigmentary changes, geographic atrophy (...) , and neovascularisation of the choriocapillaris with exudation. Leading cause of adult blindness in industrialised nations. Typically affects white people aged >55 years. Diagnosis and treatment are highly specialised and involve consultation with a retinal consultant. Definition Age-related macular degeneration (AMD) is a potentially progressive maculopathy. Arnold J. Age related macular degeneration. BMJ Clin Evid. February 2016. http://clinicalevidence.bmj.com/ (last accessed 26 September 2017). http

2018 BMJ Best Practice

6. Implantable miniature telescope (IMT) for vision loss due to end-stage age-related macular degeneration. Full Text available with Trip Pro

Implantable miniature telescope (IMT) for vision loss due to end-stage age-related macular degeneration. Age-related macular degeneration (AMD) causes progressive and irreversible damage to the retina, resulting in loss of central vision. AMD is the third leading cause of irreversible visual impairment worldwide and the leading cause of blindness in industrialized countries. Since AMD is more common in older individuals, the number of affected individuals will increase significantly

2018 Cochrane

8. [Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema]

[Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema] Optische kohärenztomografie bei neovaskulärer altersbedingter makuladegeneration sowie beim makulaödem im rahmen der diabetischen retinopathie: abschlussbericht; auftrag D15-01 [Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema] Optische kohärenztomografie bei neovaskulärer (...) altersbedingter makuladegeneration sowie beim makulaödem im rahmen der diabetischen retinopathie: abschlussbericht; auftrag D15-01 [Optical coherence tomography (OCT) for neovascular age-related macular degeneration as well as diabetic retinopathy with macular oedema] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made

2017 Health Technology Assessment (HTA) Database.

9. Subthreshold Nanosecond Laser Intervention in Intermediate Age-Related Macular Degeneration: Study Design and Baseline Characteristics of the Laser in Early Stages of Age-Related Macular Degeneration Study (Report Number 1). (Abstract)

Subthreshold Nanosecond Laser Intervention in Intermediate Age-Related Macular Degeneration: Study Design and Baseline Characteristics of the Laser in Early Stages of Age-Related Macular Degeneration Study (Report Number 1). The Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study is an investigation of the safety and efficacy of subthreshold nanosecond laser treatment to slow the progression of intermediate age-related macular degeneration (AMD). This report (...) imaging (MMI) as fundus autofluorescence-defined atrophy, spectral-domain OCT (SD-OCT)-defined atrophy, or nascent GA excluded participation.Participants were randomized to nanosecond or sham laser treatment. Twelve laser or sham spots are applied to the macular region of the study eye. Participants are reviewed in visits every 6 months with functional testing and MMI for 36 months and are re-treated at each visit (until 30 months) if an end point is not reached in the study eye.Progression to late

2019 Ophthalmology. Retina Controlled trial quality: predicted high

10. Association Between Cilioretinal Arteries and Advanced Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT). (Abstract)

Association Between Cilioretinal Arteries and Advanced Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT). Recent reports suggest that cilioretinal arteries (CRAs) confer protection against developing advanced age-related macular degeneration (AMD).To further characterize the association between the presence of a CRA and incidence of geographic atrophy (GA) or choroidal neovascularization (CNV).This cohort study (...) constituted an ad hoc secondary analysis of data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and was performed at 44 clinical centers in the United States among participants in CATT with CNV in the study eye and without advanced AMD in the fellow eye at baseline. The presence of a CRA was determined by 2 graders, masked to clinical data, using color fundus photographs, red-free fundus photographs, and fluorescein angiography. The proportion with CRAs at baseline

2019 JAMA ophthalmology

11. Miniature lens system implantation for advanced age-related macular degeneration

Miniature lens system implantation for advanced age-related macular degeneration Miniature lens system implantation for advanced Miniature lens system implantation for advanced age-related macular degener age-related macular degeneration ation Interventional procedures guidance Published: 28 September 2016 nice.org.uk/guidance/ipg565 Y Y our responsibility our responsibility This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When (...) . Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 1 of 91 1 Recommendations Recommendations 1.1 Evidence on the efficacy of miniature lens system implantation for advanced age-related macular degeneration (AMD) shows that the procedure can improve both vision and quality of life in the short term. Data on short-term safety are available for limited numbers of patients. There is currently insufficient long-term evidence on both efficacy and safety

2016 National Institute for Health and Clinical Excellence - Interventional Procedures

12. Development and testing of a patient-derived questionnaire for treatment of neovascular age-related macular degeneration: dimensions of importance in treatment of neovascular age-related macular degeneration. Full Text available with Trip Pro

Development and testing of a patient-derived questionnaire for treatment of neovascular age-related macular degeneration: dimensions of importance in treatment of neovascular age-related macular degeneration. Studies reporting on patient perspectives during treatment of neovascular age-related macular degeneration (nAMD) are limited. Thus, the aim of this study was to develop and test psychometric performance of a patient-derived questionnaire to capture important experiences during

2018 Acta ophthalmologica

13. EFFECT OF INTRAOCULAR PRESSURE-LOWERING MEDICATIONS ON NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATMENT OUTCOMES IN THE COMPARISON OF AGE-RELATED MACULAR DEGENERATION TREATMENT TRIALS. (Abstract)

EFFECT OF INTRAOCULAR PRESSURE-LOWERING MEDICATIONS ON NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATMENT OUTCOMES IN THE COMPARISON OF AGE-RELATED MACULAR DEGENERATION TREATMENT TRIALS. To evaluate the effect of intraocular pressure-lowering medications on treatment outcomes in the Comparison of AMD Treatments Trials.Secondary analysis of Comparison of AMD Treatments Trials data. Medication logs were reviewed for continuous 2-year use of agents that increased aqueous outflow (Group (...) endothelial growth factor therapy for neovascular age-related macular degeneration was associated with a trend toward greater reductions in retinal and total thickness as well as improved visual outcomes over 2 years. A similar effect was not observed to the same extent with agents that increase aqueous outflow. Because of the small sample size and secondary analysis, these findings must be cautiously interpreted and perhaps serve as a basis for future prospective studies.

2018 Retina

14. Computational modeling of retinal hypoxia and photoreceptor degeneration in patients with age-related macular degeneration. Full Text available with Trip Pro

Computational modeling of retinal hypoxia and photoreceptor degeneration in patients with age-related macular degeneration. Although drusen have long been acknowledged as a primary hallmark of dry age-related macular degeneration (AMD) their role in the disease remains unclear. We hypothesize that drusen accumulation increases the barrier to metabolite transport ultimately resulting in photoreceptor cell death. To investigate this hypothesis, a computational model was developed to evaluate

2019 PLoS ONE

15. No CFH or ARMS2 Interaction with Omega-3 Fatty Acids, Low versus High Zinc, or β-Carotene versus Lutein and Zeaxanthin on Progression of Age-Related Macular Degeneration in the Age-Related Eye Disease Study 2: Age-Related Eye Disease Study 2 Report No. 18 Full Text available with Trip Pro

No CFH or ARMS2 Interaction with Omega-3 Fatty Acids, Low versus High Zinc, or β-Carotene versus Lutein and Zeaxanthin on Progression of Age-Related Macular Degeneration in the Age-Related Eye Disease Study 2: Age-Related Eye Disease Study 2 Report No. 18 To assess whether genotypes at 2 major loci associated with age-related macular degeneration (AMD), complement factor H (CFH), or age-related maculopathy susceptibility 2 (ARMS2), modify the response to oral nutrients for the treatment of AMD (...) in the Age-Related Eye Disease Study 2 (AREDS2).Post hoc analysis of a randomized trial.White AREDS2 participants.AREDS2 participants (n = 4203) with bilateral large drusen or late AMD in 1 eye were assigned randomly to lutein and zeaxanthin, omega-3 fatty acids, both, or placebo, and most also received the AREDS supplements. A secondary randomization assessed modified AREDS supplements in 4 treatment arms: lower zinc dosage, omission of β-carotene, both, or no modification. To evaluate the progression

2019 Ophthalmology Controlled trial quality: uncertain

16. The Association of Aspirin Use with Age-Related Macular Degeneration Progression in the Age-Related Eye Disease Studies: Age-Related Eye Disease Study 2 Report No. 20. (Abstract)

The Association of Aspirin Use with Age-Related Macular Degeneration Progression in the Age-Related Eye Disease Studies: Age-Related Eye Disease Study 2 Report No. 20. To analyze the potential association between aspirin use and progression of age-related macular degeneration (AMD).Two prospective cohort studies within 2 controlled clinical trials of oral supplementation for age-related eye disease.Age-Related Eye Disease Study (AREDS) participants 55 to 80 years of age and AREDS2 participants

2019 Ophthalmology

17. Statins for age-related macular degeneration. Full Text available with Trip Pro

Statins for age-related macular degeneration. Age-related macular degeneration (AMD) is a progressive, late-onset disorder of the macula affecting central vision. It is the leading cause of blindness in people over 65 years in industrialized countries. Recent epidemiologic, genetic, and pathological evidence has shown that AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD.The objective of this review

2016 Cochrane

18. Statins for age-related macular degeneration. Full Text available with Trip Pro

Statins for age-related macular degeneration. Age-related macular degeneration (AMD) is a progressive late onset disorder of the macula affecting central vision. Age-related macular degeneration is the leading cause of blindness in people over 65 years in industrialized countries. Recent epidemiologic, genetic, and pathological evidence has shown AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD.The objective

2015 Cochrane

19. Removal of choroidal neovascular membrane in a case of macular hole after anti-VEGF therapy for age-related macular degeneration Full Text available with Trip Pro

Removal of choroidal neovascular membrane in a case of macular hole after anti-VEGF therapy for age-related macular degeneration The formation of macular hole after receiving anti-vascular endothelial growth factor (anti-VEGF) therapy is rare. We report a case of macular hole that occurred after intravitreal injection of an anti-VEGF agent for age-related macular degeneration (AMD) in a patient, who underwent vitrectomy combined with choroidal neovascularization (CNV) removal.A 64-year-old (...) female with AMD affecting her right eye received an intravitreal injection of an anti-VEGF agent. After treatment, we identified a full thickness macular hole (MH) that was associated with the rapid resolution of the macular edema and contraction of the CNV. After performing vitrectomy combined with CNV removal, the MH closed and her visual acuity improved. Examination of the removed CNV revealed a network of microvessels devoid of pericytes.and Importance: The present findings suggest that rapid

2017 American journal of ophthalmology case reports

20. Ranibizumab or bevacizumab in age-related macular degeneration?

Ranibizumab or bevacizumab in age-related macular degeneration? Prescrire IN ENGLISH - Spotlight ''In the May issue of Prescrire International: Ranibizumab or bevacizumab in AMD?'', 1 May 2016 {1} {1} {1} | | > > > In the May issue of Prescrire International: Ranibizumab or bevacizumab in AMD? Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight (...) In the May issue of Prescrire International: Ranibizumab or bevacizumab in AMD? FREE DOWNLOAD The Italian independent drug bulletin Informazioni sui Farmaci published a review comparing ranibizumab versus bevacizumab for age-related macular degeneration (AMD). Its conclusion differs from that of Prescrire’s review. A letter from Informazioni sui Farmaci's editors and Prescrire's reply explore the various scientific and policy questions surrounding these treatments. Full text available for free download

2016 Prescrire

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