Ocular and systemic safety of bevacizumab and ranibizumab in patients with neovascular age-related macular degeneration

Johnson, Davin; Sharma, Sanjay

doi:10.1097/icu.0b013e32835f8ec0

Cited by 29 publications

(20 citation statements)

References 112 publications

(57 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…4 Many cases can be treated successfully with topical or local corticosteroids, although more severe cases are often presumed infectious and treated as such. 4,5 There seems to be an underlying rate of intraocular inflammation with all anti-VEGF drugs, and clusters of higher rates of inflammation may also occur. [6][7][8][9][10][11] The mechanism of intraocular inflammation after anti-VEGF remains unknown; suggested mechanisms have included immune response to the drug itself, other protein byproducts within the medication, or differences in pH, whereas mechanisms of inflammation clusters have been attributed to silicone oil residues, silicone/protein aggregates, or endotoxins.…”

Section: Etiologymentioning

confidence: 99%

Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab

Witkin

Hahn

Murray³

et al. 2020

Journal of VitreoRetinal Diseases

146

211

View full text Add to dashboard Cite

Purpose: To analyze a case series of retinal vasculitis reported to the American Society of Retina Specialists (ASRS) following Food and Drug Administration approval of brolucizumab for treatment of neovascular age-related macular degeneration. Methods: The ASRS Research and Safety in Therapeutics Committee analyzed clinical and imaging characteristics from submitted reports of retinal vasculitis after brolucizumab. Results: Retinal vasculitis was reported in 26 eyes of 25 patients (22 [88%] female) after treatment with brolucizumab. Imaging studies were available for 24 of 26 eyes. Most cases (92%) were associated with intraocular inflammation, which presented at a mean of 25 days (range, 3-63 days) after the most recent brolucizumab injection. Mean visual acuity (VA) was 20/52 (range, 20/25-4/200) before the adverse event, 20/151 (range, 20/25-hand motion) at presentation of the adverse event, and 20/243 (range, 20/30-light perception) at last follow-up. Twelve eyes (46%) had a greater than 3-line decrease in VA at final follow-up, and 12 eyes (46%) had a final VA of 20/200 or worse. Analysis of retinal imaging identified vasculopathy that involved retinal arteries (91%), retinal veins (79%), and choroidal vessels (48%). Occlusive disease was apparent on imaging in 83% of eyes. Treatment approaches were varied. Conclusions: Retinal vasculitis has been identified in a series of eyes following brolucizumab. Although a few eyes in this series were asymptomatic or minimally symptomatic, some eyes had significant vision loss. A careful examination for signs of active inflammation prior to brolucizumab injection is recommended. Once vasculopathy is suspected, angiographic imaging may help define the spectrum of involvement. Optimal treatment strategies remain unknown.

show abstract

Section: Etiologymentioning

confidence: 99%

Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab

Witkin

Hahn

Murray³

et al. 2020

Journal of VitreoRetinal Diseases

146

211

View full text Add to dashboard Cite

show abstract

“…In human studies, Avery et al 96 found that the systemic exposure after the third monthly intravitreal injection was 13-fold greater for aflibercept and 70-fold greater for bevacizumab than for ranibizumab. Another report reviewed differences in both ocular and systemic safety between intravitreal bevacizumab and ranibizumab in the setting of neovascular AMD 91. Serious adverse events associated with either bevacizumab or ranibizumab injections are generally rare.…”

Section: Therapeutic Strategiesmentioning

confidence: 99%

Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA)

Schmidt‐Erfurth

Chong

Loewenstein³

et al. 2014

Br J Ophthalmol

530

456

View full text Add to dashboard Cite

Age-related macular degeneration (AMD) is still referred to as the leading cause of severe and irreversible visual loss world-wide. The disease has a profound effect on quality of life of affected individuals and represents a major socioeconomic challenge for societies due to the exponential increase in life expectancy and environmental risks. Advances in medical research have identified vascular endothelial growth factor (VEGF) as an important pathophysiological player in neovascular AMD and intraocular inhibition of VEGF as one of the most efficient therapies in medicine. The wide introduction of anti-VEGF therapy has led to an overwhelming improvement in the prognosis of patients affected by neovascular AMD, allowing recovery and maintenance of visual function in the vast majority of patients. However, the therapeutic benefit is accompanied by significant economic investments, unresolved medicolegal debates about the use of off-label substances and overwhelming problems in large population management. The burden of disease has turned into a burden of care with a dissociation of scientific advances and real-world clinical performance. Simultaneously, ground-breaking innovations in diagnostic technologies, such as optical coherence tomography, allows unprecedented high-resolution visualisation of disease morphology and provides a promising horizon for early disease detection and efficient therapeutic follow-up. However, definite conclusions from morphologic parameters are still lacking, and valid biomarkers have yet to be identified to provide a practical base for disease management. The European Society of Retina Specialists offers expert guidance for diagnostic and therapeutic management of neovascular AMD supporting healthcare givers and doctors in providing the best state-of-the-art care to their patients.Trial registration numberNCT01318941.

show abstract

“…The ocular route of administration is classified as "Very High" risk in the risk assessment framework not because this route is particularly associated with the generation of antibody responses, but rather because the consequences of ATA or anti-HCP antibody development in the eye can be quite serious. Immune responses within the eye can result in inflammation and/or altered intraocular pressure, which may lead to retinal damage and impaired vision (Johnson and Sharma, 2013).…”

Section: Route Of Administrationmentioning

confidence: 99%

Host cell proteins in biotechnology‐derived products: A risk assessment framework

Zafra¹,

Quarmby²,

Francissen³

et al. 2015

Biotech & Bioengineering

View full text Add to dashboard Cite

To manufacture biotechnology products, mammalian or bacterial cells are engineered for the production of recombinant therapeutic human proteins including monoclonal antibodies. Host cells synthesize an entire repertoire of proteins which are essential for their own function and survival. Biotechnology manufacturing processes are designed to produce recombinant therapeutics with a very high degree of purity. While there is typically a low residual level of host cell protein in the final drug product, under some circumstances a host cell protein(s) may copurify with the therapeutic protein and, if it is not detected and removed, it may become an unintended component of the final product. The purpose of this article is to enumerate and discuss factors to be considered in an assessment of risk of residual host cell protein(s) detected and identified in the drug product. The consideration of these factors and their relative ranking will lead to an overall risk assessment that informs decision-making around how to control the levels of host cell proteins.

show abstract

Ocular and systemic safety of bevacizumab and ranibizumab in patients with neovascular age-related macular degeneration

Abstract: Although rare, adverse events with off-label use of bevacizumab are more common than with ranibizumab. Continued study into long-term safety of the two agents is warranted.

Cited by 29 publications

References 112 publications

Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab

Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab

Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA)

Host cell proteins in biotechnology‐derived products: A risk assessment framework

Contact Info

Product

Resources

About