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  1. Book: DNA- and RNA-based gene therapies in ophthalmology: preclinical, clinical and commercial considerations

    Ciulla, Thomas

    (International ophthalmology clinics ; volume 61, number 3 (Summer 2021))

    2021  

    Title variant DNA- and RNA-based gene therapies in ophthalmology
    Author's details edited by guest editors: Thomas Ciulla, MD, MBA; Mark E. Pennessi, MD, PhD; Szilárd Kiss, MD; Emmett T. Cunningham Jr, MD, PhD, MPH
    Series title International ophthalmology clinics ; volume 61, number 3 (Summer 2021)
    Collection
    Language English
    Size vi, 215 Seiten, Illustrationen
    Publisher Lippincott Williams & Wilkins
    Publishing place Philadelphia, Pennsylvania
    Publishing country United States
    Document type Book
    HBZ-ID HT021053063
    Database Catalogue ZB MED Medicine, Health

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  2. Book: DNA- and RNA-based gene therapies in ophthalmology: inherited and non-inherited retinal disease

    Ciulla, Thomas

    DNA- and RNA-based gene therapies in ophthalmology

    (International ophthalmology clinics ; volume 61, number 4 (Fall 2021))

    2021  

    Author's details edited by guest editors: Thomas Ciulla, MD, MBA; Mark E. Pennessi, MD, PhD; Szilárd Kiss, MD; Emmett T. Cunningham Jr, MD, PhD, MPH
    Series title International ophthalmology clinics ; volume 61, number 4 (Fall 2021)
    Collection
    Language English
    Size vii, 270 Seiten, Illustrationen
    Publisher Lippincott Williams & Wilkins
    Publishing place Philadelphia, Pennsylvania
    Publishing country United States
    Document type Book
    HBZ-ID HT021150364
    Database Catalogue ZB MED Medicine, Health

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  3. Article ; Online: The complement system: a novel therapeutic target for age-related macular degeneration.

    Shughoury, Aumer / Sevgi, Duriye D / Ciulla, Thomas A

    Expert opinion on pharmacotherapy

    2023  Volume 24, Issue 17, Page(s) 1887–1899

    Abstract: Introduction: With the recent FDA approvals of pegcetacoplan (SYFOVRE, Apellis Pharmaceuticals) and avacincaptad pegol (IZERVAY, Astellas Pharmaceuticals), modulation of the complement system has emerged as a promising therapeutic approach for slowing ... ...

    Abstract Introduction: With the recent FDA approvals of pegcetacoplan (SYFOVRE, Apellis Pharmaceuticals) and avacincaptad pegol (IZERVAY, Astellas Pharmaceuticals), modulation of the complement system has emerged as a promising therapeutic approach for slowing progression of geographic atrophy (GA) in AMD.
    Areas covered: This article reviews the current understanding of the complement system, its role in AMD, and the various complement-targeting therapies in development for the treatment of GA, including monoclonal antibodies, aptamers, protein analogs, and gene therapies. Approved and investigational agents have largely focused on interfering with the activity of complement components 3 and 5, owing to their central roles in the classical, lectin, and alternative complement pathways. Other investigational therapies have targeted formation of membrane attack complex (a terminal step in the complement cascade which leads to cell lysis), complement factors H and I (which serve regulatory functions in the alternative pathway), complement factors B and D (within the alternative pathway), and complement component 1 (within the classical pathway). Clinical trials investigating these agents are summarized, and the potential benefits and limitations of these therapies are discussed.
    Expert opinion: Targeting the complement system is a promising therapeutic approach for slowing the progression of GA in AMD, potentially improving visual outcomes. However, increased risk of exudative conversion must be considered, and further research is required to identify clinical criteria and best practices for initiating complement inhibitor therapy for GA.
    MeSH term(s) Humans ; Macular Degeneration/drug therapy ; Macular Degeneration/metabolism ; Geographic Atrophy/drug therapy ; Geographic Atrophy/etiology ; Geographic Atrophy/metabolism ; Immunologic Factors/therapeutic use ; Therapies, Investigational ; Pharmaceutical Preparations
    Chemical Substances Immunologic Factors ; Pharmaceutical Preparations
    Language English
    Publishing date 2023-09-11
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2001535-5
    ISSN 1744-7666 ; 1465-6566
    ISSN (online) 1744-7666
    ISSN 1465-6566
    DOI 10.1080/14656566.2023.2257604
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety.

    Yeh, Steven / Ciulla, Thomas

    The American journal of managed care

    2023  Volume 29, Issue 2 Suppl, Page(s) S19–S28

    Abstract: Patients with macular edema (ME) associated with uveitis (UME) are at risk for vision loss and decreased quality of life, and they often experience high health care costs and rates of workforce absenteeism. Systemically or locally delivered ... ...

    Abstract Patients with macular edema (ME) associated with uveitis (UME) are at risk for vision loss and decreased quality of life, and they often experience high health care costs and rates of workforce absenteeism. Systemically or locally delivered corticosteroids are the mainstay of treatment for UME. Although traditional corticosteroid treatments may demonstrate high levels of efficacy, systemic delivery carries the risk of potentially serious systemic adverse effects (AEs), and standard local modes of delivery may be associated with low bioavailability in posterior ocular tissues and steroid-associated AEs due to anterior ocular tissue exposure. Drug injection into the suprachoroidal space (SCS) allows for targeted delivery to chorioretinal tissues with high bioavailability in the posterior segment, as well as for inherent drug sequestration away from the anterior segment, which may lower the risk of AEs associated with anterior tissue exposure to steroids. A novel triamcinolone acetonide (TA) injectable suspension formulated for administration to the SCS, SCS-TA (Xipere®; Bausch + Lomb), received FDA approval in 2021 for the treatment of UME. It is administered via the SCS Microinjector® (Clearside Biomedical, Inc), a device specifically designed for SCS delivery of ocular therapeutics. This approval was based on results from the phase 3 PEACHTREE clinical trial (NCT02595398) that demonstrated the clinical efficacy-including significantly increased visual acuity and decreased central subfield thickness-and safety of SCS-TA in patients with UME. Results from this trial, as well as from its long-term observational extension (MAGNOLIA; NCT02952001) and an open-label safety study (AZALEA; NCT03097315), support the possibility that treatment with SCS-TA may address the burden of disease in patients with UME.
    MeSH term(s) Humans ; Triamcinolone Acetonide/adverse effects ; Glucocorticoids/adverse effects ; Macular Edema/etiology ; Macular Edema/complications ; Quality of Life ; Choroid ; Uveitis/complications ; Uveitis/drug therapy ; Treatment Outcome
    Chemical Substances Triamcinolone Acetonide (F446C597KA) ; Glucocorticoids
    Language English
    Publishing date 2023-02-14
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2035781-3
    ISSN 1936-2692 ; 1088-0224 ; 1096-1860
    ISSN (online) 1936-2692
    ISSN 1088-0224 ; 1096-1860
    DOI 10.37765/ajmc.2023.89324
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Book: Retina and optic nerve imaging

    Ciulla, Thomas A.

    2003  

    Author's details ed. Thomas A. Ciulla
    Keywords Retina / physiopathology ; Optic Nerve / physiopathology ; Diagnostic Imaging / methods ; Diagnostic Techniques, Ophthalmological ; Eye Diseases / diagnosis ; Retina/Imaging ; Optic nerve/Imaging
    Subject code 617.730754
    Language English
    Size X, 369 S. : Ill.
    Publisher Lippincott Williams & Wilkins
    Publishing place Philadelphia, Pa. u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT013811323
    ISBN 0-7817-3433-9 ; 978-0-7817-3433-2
    Database Catalogue ZB MED Medicine, Health

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    2003 A 3703 order for loan Magazin

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  6. Article ; Online: Molecular Genetic Mechanisms in Age-Related Macular Degeneration.

    Shughoury, Aumer / Sevgi, Duriye Damla / Ciulla, Thomas A

    Genes

    2022  Volume 13, Issue 7

    Abstract: Age-related macular degeneration (AMD) is among the leading causes of irreversible blindness worldwide. In addition to environmental risk factors, such as tobacco use and diet, genetic background has long been established as a major risk factor for the ... ...

    Abstract Age-related macular degeneration (AMD) is among the leading causes of irreversible blindness worldwide. In addition to environmental risk factors, such as tobacco use and diet, genetic background has long been established as a major risk factor for the development of AMD. However, our ability to predict disease risk and personalize treatment remains limited by our nascent understanding of the molecular mechanisms underlying AMD pathogenesis. Research into the molecular genetics of AMD over the past two decades has uncovered 52 independent gene variants and 34 independent loci that are implicated in the development of AMD, accounting for over half of the genetic risk. This research has helped delineate at least five major pathways that may be disrupted in the pathogenesis of AMD: the complement system, extracellular matrix remodeling, lipid metabolism, angiogenesis, and oxidative stress response. This review surveys our current understanding of each of these disease mechanisms, in turn, along with their associated pathogenic gene variants. Continued research into the molecular genetics of AMD holds great promise for the development of precision-targeted, personalized therapies that bring us closer to a cure for this debilitating disease.
    MeSH term(s) Complement Factor H/genetics ; Humans ; Macular Degeneration/genetics ; Molecular Biology ; Polymorphism, Single Nucleotide ; Proteins/genetics
    Chemical Substances Proteins ; Complement Factor H (80295-65-4)
    Language English
    Publishing date 2022-07-12
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527218-4
    ISSN 2073-4425 ; 2073-4425
    ISSN (online) 2073-4425
    ISSN 2073-4425
    DOI 10.3390/genes13071233
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  7. Article ; Online: Advancements in ocular gene therapy delivery: vectors and subretinal, intravitreal, and suprachoroidal techniques.

    Kovacs, Kyle D / Ciulla, Thomas A / Kiss, Szilárd

    Expert opinion on biological therapy

    2022  Volume 22, Issue 9, Page(s) 1193–1208

    Abstract: Introduction: Ocular gene therapy represents fertile ground for rapid innovation, with ever-expanding therapeutic strategies, molecular targets, and indications.: Areas covered: Potential indications for ocular gene therapy have classically focused ... ...

    Abstract Introduction: Ocular gene therapy represents fertile ground for rapid innovation, with ever-expanding therapeutic strategies, molecular targets, and indications.
    Areas covered: Potential indications for ocular gene therapy have classically focused on inherited retinal disease (IRD) but more recently include acquired retinal diseases, such as neovascular age-related macular degeneration, geographic atrophy, and diabetic retinopathy. Ocular gene therapy strategies have proliferated recently, and include gene augmentation, gene inactivation, gene editing, RNA modulation, and gene-independent gene augmentation. Viral vector therapeutic constructs include adeno-associated virus and lentivirus and continue to evolve through directed evolution and rationale design. Ocular gene therapy administration techniques have expanded beyond pars plana vitrectomy with subretinal injection to intravitreal injection and suprachoroidal injection.
    Expert opinion: The success of treatment for IRD, paired with the promise of clinical research in acquired retinal diseases and in administration techniques, has raised the possibility of in-office gene therapy for common retinal disorders within the next 5 to 10 years.
    MeSH term(s) Dependovirus/genetics ; Gene Transfer Techniques ; Genetic Therapy/methods ; Genetic Vectors ; Humans ; Intravitreal Injections ; Retinal Diseases/genetics ; Retinal Diseases/therapy
    Language English
    Publishing date 2022-09-19
    Publishing country England
    Document type Journal Article
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2022.2121646
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Safety and Efficacy of CLS-TA by Anatomic Location of Inflammation: Results from the Phase 3 PEACHTREE Clinical Trial.

    Shah, Milan / Albini, Thomas / Nguyen, Quan / Wykoff, Charles / Barakat, Mark / Khurana, Rahul N / Kapik, Barry / Ciulla, Thomas A

    Ocular immunology and inflammation

    2024  , Page(s) 1–8

    Abstract: Purpose: To explore the efficacy of CLS-TA, a proprietary suprachoroidal injectable suspension of triamcinolone acetonide, in noninfectious uveitis (NIU) with macular edema (ME), categorized by anatomic subtype.: Methods: Patients diagnosed with ME ... ...

    Abstract Purpose: To explore the efficacy of CLS-TA, a proprietary suprachoroidal injectable suspension of triamcinolone acetonide, in noninfectious uveitis (NIU) with macular edema (ME), categorized by anatomic subtype.
    Methods: Patients diagnosed with ME associated with NIU of any etiology and anatomic subtype were eligible for the phase 3 PEACHTREE trial of CLS-TA. Post-hoc analyses were performed, stratified by discrete anatomic subtype of uveitis (anterior, intermediate, posterior, and panuveitis.).
    Results: Across all anatomic subtypes at 24 weeks, patients receiving CLS-TA at baseline and week 12 demonstrated mean increases in BCVA ranging from +12.1 to +15.9 letters, mean central subfield thickness (CST) improvement ranging from -120.1 µm to -189.0 µm, and IOP changes ranging from +0.5 to +3.1 mmHg. Overall, reports of adverse events were similar among subtypes.
    Conclusions: Irrespective of the uveitic anatomic subtype among patients treated for ME associated with NIU, a clinical benefit in participants treated with CLS-TA was demonstrated, with a comparable safety profile.
    Language English
    Publishing date 2024-01-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 1193873-0
    ISSN 1744-5078 ; 0927-3948
    ISSN (online) 1744-5078
    ISSN 0927-3948
    DOI 10.1080/09273948.2023.2262015
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Microinjection via the suprachoroidal space: a review of a novel mode of administration.

    Ciulla, Thomas / Yeh, Steven

    The American journal of managed care

    2022  Volume 28, Issue 13 Suppl, Page(s) S243–S252

    Abstract: Standard ocular drug delivery methods generally are safe and effective for treating diseases of the eye. However, many routes of administration carry the risk of adverse effects due to drug exposure to anterior ocular tissues. Additionally, these ... ...

    Abstract Standard ocular drug delivery methods generally are safe and effective for treating diseases of the eye. However, many routes of administration carry the risk of adverse effects due to drug exposure to anterior ocular tissues. Additionally, these delivery methods may not result in high and consistent levels of a therapeutic agent delivered to target tissues for diseases affecting the posterior segment of the eye. Injection into the suprachoroidal space (SCS) represents an alternative method of ocular drug delivery to the posterior segment. SCS injection facilitates targeted distribution to affected chorioretinal tissues for potential efficacy benefits, compartmentalization away from unaffected anterior segment tissues for potential safety benefits, and a high degree of bioavailability. Furthermore, the SCS may serve as a drug depot for long-acting drug delivery of small-molecule suspensions. Until recently, drug delivery to the SCS could be achieved only in the operating room setting with anesthetic immobilization of the eye and surgical dissection through the sclera. A novel microneedle device, the SCS Microinjector® (Clearside Biomedical, Inc) was developed to permit physicians to administer therapies safely and reliably into the SCS in the office setting. Successful use of SCS injection has been demonstrated with triamcinolone acetonide injectable suspension (Xipere®, Bausch + Lomb), a novel formulation optimized for use with the SCS Microinjector®. FDA approval of this combination drug and device for the treatment of macular edema associated with uveitis (UME) was based on outcomes from the phase 3 PEACHTREE study (NCT02595398); other important studies included its long-term observational extension (MAGNOLIA; NCT02952001) and an open-label safety study (AZALEA; NCT03097315). The SCS Microinjector® together with triamcinolone acetonide injectable suspension for use in the SCS presents an opportunity for safe and effective drug delivery for the treatment of UME and, potentially, for broader use with alternate medications to treat other ocular diseases that impact chorioretinal tissues (eg, age-related macular degeneration, diabetic retinopathy, choroidal melanoma).
    MeSH term(s) Humans ; Microinjections ; Choroid ; Triamcinolone Acetonide/pharmacology ; Needles ; Choroidal Effusions ; Observational Studies as Topic
    Chemical Substances Triamcinolone Acetonide (F446C597KA)
    Language English
    Publishing date 2022-11-17
    Publishing country United States
    Document type Review ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2035781-3
    ISSN 1936-2692 ; 1088-0224 ; 1096-1860
    ISSN (online) 1936-2692
    ISSN 1088-0224 ; 1096-1860
    DOI 10.37765/ajmc.2022.89270
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  10. Article ; Online: The evolving therapeutic landscape of diabetic retinopathy.

    Shughoury, Aumer / Bhatwadekar, Ashay / Jusufbegovic, Denis / Hajrasouliha, Amir / Ciulla, Thomas A

    Expert opinion on biological therapy

    2023  Volume 23, Issue 10, Page(s) 969–985

    Abstract: Introduction: Diabetic retinopathy (DR) is a leading cause of blindness worldwide. Recent decades have seen rapid progress in the management of diabetic eye disease, evolving from pituitary ablation to photocoagulation and intravitreal pharmacotherapy. ... ...

    Abstract Introduction: Diabetic retinopathy (DR) is a leading cause of blindness worldwide. Recent decades have seen rapid progress in the management of diabetic eye disease, evolving from pituitary ablation to photocoagulation and intravitreal pharmacotherapy. The advent of effective intravitreal drugs inhibiting vascular endothelial growth factor (VEGF) marked a new era in DR therapy. Sustained innovation has since produced several promising biologics targeting angiogenesis, inflammation, oxidative stress, and neurodegeneration.
    Areas covered: This review surveys traditional, contemporary, and emerging therapeutics for DR, with an emphasis on anti-VEGF therapies, receptor tyrosine kinase inhibitors, angiopoietin-Tie2 pathway inhibitors, integrin pathway inhibitors, gene therapy 'biofactory' approaches, and novel systemic therapies. Some of these investigational therapies are being delivered intravitreally via sustained release technologies for extended durability. Other investigational agents are being delivered non-invasively via topical and systemic routes. These strategies hold promise for early and long-lasting treatment of DR.
    Expert opinion: The evolving therapeutic landscape of DR is rapidly expanding our toolkit for the effective and durable treatment of blinding eye disease. However, further research is required to validate the efficacy of novel therapeutics and characterize real world outcomes.
    MeSH term(s) Humans ; Diabetic Retinopathy/therapy ; Ranibizumab ; Angiogenesis Inhibitors/therapeutic use ; Vascular Endothelial Growth Factor A ; Macular Edema/drug therapy ; Macular Edema/etiology ; Macular Edema/surgery ; Intravitreal Injections ; Bevacizumab/therapeutic use ; Recombinant Fusion Proteins/therapeutic use ; Diabetes Mellitus
    Chemical Substances Ranibizumab (ZL1R02VT79) ; Angiogenesis Inhibitors ; Vascular Endothelial Growth Factor A ; Bevacizumab (2S9ZZM9Q9V) ; Recombinant Fusion Proteins
    Language English
    Publishing date 2023-08-14
    Publishing country England
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2023.2247987
    Database MEDical Literature Analysis and Retrieval System OnLINE

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