VEGF is a growth factor that promotes abnormal blood vessel growth in the retina and causes vision loss. Anti-VEGF drugs like ranibizumab (Lucentis), bevacizumab (Avastin), and pegaptanib (Macugen) work by blocking VEGF and stopping this blood vessel growth. Ranibizumab was designed specifically for eye injections and has a short half-life, while bevacizumab was designed for cancer but is also used "off-label" in the eye. Clinical trials found that both drugs are effective in treating wet AMD, diabetic retinopathy, and other retinal diseases, but ranibizumab may have a slightly lower risk of rare side effects due to its shorter exposure in
Accommodation/ Accommodation of Eye, Measurement of Accommodation of Eye (hea...Bikash Sapkota
CLICK HERE TO DOWNLOAD FULL PPT ❤❤ https://healthkura.com/measurement-of-accommodation-of-eye/ ❤❤
Dear viewers Check Out my other piece of works at ❤❤❤ https://healthkura.com ❤❤❤
Measurement of Accommodation of eye:
Amplitude, Facility,
Relative Accommodation, Fatigue, Lag,
Dynamic Retinoscopy
Presentation Layout:
-Introduction to accommodation of eye
-Mechanism
-Components
-Measurement of accommodation of eye
- Amplitude
- Facility
- Relative accommodation
- Lag
-Dynamic Retinoscopy
Accommodation
-dioptric adjustment of the crystalline lens of the eye
- to obtain clear vision for a given target of regard
-process by which the refractive power of eye is altered
- to ensure a clear retinal image
For further reading
-Clinical Procedures in Optometry by J.D. Bartlett, J.B. Eskridge, J.F. Amos
-Primary Care Optometry by Theodere Grosvenor
-Borish’s Clinical Refraction by W.J. Benjamin
-Clinical Procedures for Ocular examination by Carlson et al
-American Academy of Ophthalmology
-Optometric Clinical Practice Guideline by American Optometric Association
-Internet
Follow me to get in touch with optometric and ophthalmic updates
Retinal vein occlusion (RVO) is an obstruction of the retinal venous system by thrombus formation and may involve the central, hemi-central or branch retinal vein.
The most common aetiological factor is compression by adjacent atherosclerotic retinal arteries.
Other possible causes are external compression or disease of the vein wall e.g. vasculitis.
It describes about the procedure of Hess charting. it serves as a great tool to understand the concepts involved. Suitable for optometry course. This is not a routine procedure but an important procedure which is used in diagnosis.
Apart from its established role in Age related maculopathy, Ani-Vegf have other usage too. Presently clinical study reports are coming in showing encouraging results.
Accommodation/ Accommodation of Eye, Measurement of Accommodation of Eye (hea...Bikash Sapkota
CLICK HERE TO DOWNLOAD FULL PPT ❤❤ https://healthkura.com/measurement-of-accommodation-of-eye/ ❤❤
Dear viewers Check Out my other piece of works at ❤❤❤ https://healthkura.com ❤❤❤
Measurement of Accommodation of eye:
Amplitude, Facility,
Relative Accommodation, Fatigue, Lag,
Dynamic Retinoscopy
Presentation Layout:
-Introduction to accommodation of eye
-Mechanism
-Components
-Measurement of accommodation of eye
- Amplitude
- Facility
- Relative accommodation
- Lag
-Dynamic Retinoscopy
Accommodation
-dioptric adjustment of the crystalline lens of the eye
- to obtain clear vision for a given target of regard
-process by which the refractive power of eye is altered
- to ensure a clear retinal image
For further reading
-Clinical Procedures in Optometry by J.D. Bartlett, J.B. Eskridge, J.F. Amos
-Primary Care Optometry by Theodere Grosvenor
-Borish’s Clinical Refraction by W.J. Benjamin
-Clinical Procedures for Ocular examination by Carlson et al
-American Academy of Ophthalmology
-Optometric Clinical Practice Guideline by American Optometric Association
-Internet
Follow me to get in touch with optometric and ophthalmic updates
Retinal vein occlusion (RVO) is an obstruction of the retinal venous system by thrombus formation and may involve the central, hemi-central or branch retinal vein.
The most common aetiological factor is compression by adjacent atherosclerotic retinal arteries.
Other possible causes are external compression or disease of the vein wall e.g. vasculitis.
It describes about the procedure of Hess charting. it serves as a great tool to understand the concepts involved. Suitable for optometry course. This is not a routine procedure but an important procedure which is used in diagnosis.
Apart from its established role in Age related maculopathy, Ani-Vegf have other usage too. Presently clinical study reports are coming in showing encouraging results.
Clinical and Pharmacoeconomic analysis was extensivley done on Eylea for its placement on a hypothetical health plans formulary for Macular Degeneration. Information was presented to a panel of pharmacy professionals in managed care and industry
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Title:
Choosing amongst current modalities to manage Diabetic Retinopathy
At Medical Retina Clinic, Eye Department WAPDA Teaching Hospital Complex Lahore
Objective:
1. To review the current management options for DR
2. To share author’s four years follow up from Jan 2008 to Nov 2011 at Medical Retina Clinic, Eye Department WAPDA Teaching Hospital Complex Lahore.
3. Discussion on future Trends in management of DR.
Synopsis:
Diabetic retinopathy is the leading cause of new blindness in the world,
Argon LASER treatment has established itself as a gold standard in the management of DR. Intravitreal therapies in the form anti VEGF agents and steroids are also being widely used nationally and internationally. These therapies do not replace but complement each other.
Author will share his four years experience at Medical Retina clinic WAPDA hospital complex Lahore. 125 patients with DR were enrolled during this period. Treatment modalities used, included Argon Green Laser, Intravitreal Anti VEGF (Bevacizumab), Intravitreal Triamcinolone and subtenon Triamcinolone. Staging and severity of the disease as well as response to the offered therapy were the parameters used to tailor the treatment options.
Dr. Zia ul Mazhry
FRCS (Edin), FRCS (Glasgow), FCPS, CICOphth (UK)
Asstt Professor Central Park Medical College Lahore.
Consultant Eye Surgeon and Head of Eye Department
Wapda Teaching Hospital Complex
210 Feroz Pur Road Lahore.
Website: www.EyeAcuity.com
mazhry@yahoo.com
03004401151
Clinical trials established in 2005 the efficacy of Ranibizumab (Lucentis, Genentech) for the treatment of neovascular age-related macular degeneration (wetAMD), the leading cause of legal blindness in the United States.This disease is affecting people over the age of 65 with a prevalence of 1.6 million and 200000 new cases per year in the USA .While awaiting approval for ranibizumab from the Food and Drug Administration, ophthalmologists began treating neovascular AMD with off-label use of bevacizumab (Avastin, Genentech), since the drug had a target specificity similar to that of ranibizumab and was available at low cost for about 50$ per monthly injection Vs 1950$ for Lucentis monthly injection.
Ranibizumab received the FDA approuval in 2006 to treat specifically the wetAMD,there was a huge debate about the cost effectiveness and the reimbursement of Lucentis in comparaison with Avastin for treating the eye disease.
This paper explores the dilemma from different angles.First,it make the emphasize on the need of realizing a head to head comparative study between the two drugs and the means to finance and to launch this study since many roadblocks have been identified.
Then, it explores and analyzes the Genentech reaction facing this problem and their strategy to emphasize on the higher risk of death with Avastin, as compared to Lucentis in one hand and in the other hand their strategy to extend the ophthalmologic indications for Lucentis, including diabetic macula edema (DME).
Finally it explores what value should be put on safety in health technology assessments HTAs by developing that we can’t just consider the dollar value of medicine alone but we need to consider the cost of adverse events caused by the treatment and the cost of living with these adverse events
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
3. VEGF
• VEGF is a short form for Vascular Endothelial
Growth Factor, which is responsible for growth
of blood vessels. Besides having a role in
normal vascular growth, VEGF is also
responsible for many retinal diseases by
causing new vessels growth and by increasing
leakage and thus causing retinal swelling
3
4. VEGF-A
• VEGF-A is a chemical signal that stimulates
angiogenesis in a variety of diseases,
especially in cancer. Bevacizumab was the first
clinically available angiogenesis inhibitor in
the United States
4
5. Anti-VEGF
• The anti-VEGF agents block the VEGF
molecules and thus benefit the patients by
decreasing the abnormal and harmful new
blood vessels formation and by decreasing the
leakage and swelling of the retina.
• This leads to stabilization of vision and even
improvement in vision in many cases.
5
6. Anti-VEGF
• These agents are being used for many eye diseases, especially
for :
• -wet form of AMD (Age related Macular Degeneration).
• -CNVM (Choroidal Neo Vascular Membrane).
-Severe Diabetic Retinopathy.
-Macular Edema (swelling)
-Vascular Blocks.
-Neovascular Glaucoma (NVG).
-Vitreous Hemorrhage, etc.
These retinal diseases, which were earlier considered incurable,
or had very poor results with existing treatments are now
being tackled with good results with these anti-VEGF agents. 6
7. Anti-VEGF
• there are mainly three injections available
with us for treatment.
• These are :
1-Lucentis (Ranibizumab)
2- Avastin (bevacizumab)
3-Macugen(pegaptanib)
7
11. Evolution of Anti VEGF :
• Evolution of Anti VEGF Macugen (pegaptanib
sodium, Eyetech/Pfizer), Off-label use of
Avastin (bevacizumab, Genentech) ,Lucentis
(ranibizumab, Genentech) That not only
slowed vision loss or maintained current visual
acuity, but also offered the potential to
improve and even restore functional vision.
• Others :Anecorative acetate RNA
interference, VEGF Trap
11
12. Pegaptanib
• Pegaptanib sodium injection (brand name
Macugen) is an anti-angiogenic medicine for
the treatment of neovascular (wet) age-
related macular degeneration (AMD).
• It was discovered by Gilead Sciences and
licensed in 2000 to EyeTech Pharmaceuticals.
• Approval was granted by the U.S. Food and
Drug Administration (FDA) in December 2004.
12
13. Pegaptanib
• Pegaptanib is a anti-VEGF molecule, a single
strand of nucleic acid that binds with specificity
to a particular target. Pegaptanib specifically
binds to VEGF 165, a protein that plays a critical
role in angiogenesis (the formation of new blood
vessels) and increased permeability (leakage from
blood vessels), two of the primary pathological
processes responsible for the vision loss
associated with neovascular AMD.
• Pegaptanib is administered in a 0.3 mg dose once
every 6 weeks by intravitreal injection.
13
14. Safety profile of pegaptanib
• Results:
• As in years 1 and 2, pegaptanib was well tolerated in
year 3. Adverse events were mainly ocular in nature,
mild, transient and injection-related. Serious adverse
events were rare. No evidence of systemic safety
signals attributed to vascular endothelial growth factor
inhibition arose in year 3. There were no findings in
relation to vital signs or electrocardiogram results
suggesting a relationship to pegaptanib treatment.
• Conclusion:
• The 3-year safety profile of pegaptanib sodium was
favourable in patients with NV-AMD.
14
15. Bevacizumab : Avastin
• Bevacizumab :
• Bevacizumab Intravitreal bevacizumab (IVB)
(Avastin,Genentech) Humanized monoclonal
antibody to all forms of VEGF- A .
• FDA-approved for adjunct intravenous
antiangiogenic treatment of metastatic colorectal
cancer in 2004. It was initially studied for the
treatment of exudative AMD with intravenous
delivery, with Promising results
15
16. Bevacizumab : Avastin
• Bevacizumab binds directly to VEGF to form a
protein complex which is incapable of further
binding to VEGF receptor sites (which would
initiate vessel growth) effectively reducing
available VEGF.
16
17. Bevacizumab : Avastin
• Bevacizumab has recently been used by ophthalmologists
in an off-label use as an intravitreal agent in the treatment
of proliferative (neovascular) eye diseases, particularly for
choroidal neovascular membrane (CNV) in AMD. Although
not currently approved by the FDA for such use, the
injection of 1.25-2.5 mg of bevacizumab into the vitreous
cavity has been performed without significant intraocular
toxicity.
• Many retina specialists have noted impressive results in
the setting of CNV, proliferative diabetic retinopathy,
neovascular glaucoma, diabetic macular edema,
retinopathy of prematurity and macular edema secondary
to retinal vein occlusions.
17
18. Avastin safety profile
• Can a drug for which a Food and Drug Administration
(FDA) warning has been issued be safe? The question
of safety using off‐label intravitreal bevacizumab
(Avastin Genentech, South San Francisco, California,
USA; Roche AG, Basle, Switzerland) is a concern among
ophthalmologists around the globe. This is one of the
key aspects of The international intravitreal
bevacizumab safety survey: using the internet to assess
drug safety worldwide published by A Fung et al. Why
else would 70 centres from 12 countries voluntarily
report on >7000 injections in >5000 patients using an
internet‐based questionnaire within just 6 months?
18
19. Ranibizumab : Lucentis
• Ranibizumab :
• Ranibizumab During the same time period, intravitreal
ranibizumab (Lucentis, Genentech) A fab fragment of
the bevacizumab humanized monoclonal antibody, was
undergoing US FDA clinical trial testing for neovascular
AMD in 2006 at 0.5mg intravitreally.
• Results from these clinical trials suggested that
treatment of exudative AMD with Intravitreal
ranibizumab was superior with rates of visual
improvement not previously achieved to those
reported in the pegaptanib phase III trials
19
20. Ranibizumab : Lucentis
• trade name (Lucentis) is a monoclonal antibody
fragment (Fab) derived from the same parent
mouse antibody as bevacizumab (Avastin). It is
much smaller than the parent molecule and has
been affinity matured to provide stronger binding
to VEGF-A.
• It is an anti-angiogenic that has been approved
to treat the "wet" type of age-related macular
degeneration (AMD, also ARMD), a common form
of age-related vision loss.
20
21. Ranibizumab : Lucentis
• Ranibizumab sells for $1,593 per dose, compared
to bevacizumab, which can be prepared for
macular degeneration treatment in doses that
cost $42. Clinical trials have shown both to be
equally effective; however there were some
reports of infection after dividing bevacizumab
into smaller doses.
• Ranibizumab was developed by Genentech and is
marketed in the United States by Genentech and
elsewhere by Novartis,under the brand name
Lucentis.
21
23. Safety profile of ranibizumab :
• Safety profile of ranibizumab Serious ocular
adverse events in 2 year MARINA study for
ranibizumab 0.5 mg:
• Endophthalmitis – 1.3%
• Uveitis – 1.3% .
• Retinal tear – 0.4%
• Lens damage – 0.4%
23
24. Safety profile of ranibizumab :
•
• Safety profile of ranibizumab Serious ocular
adverse events in 1 year ANCHOR study for
ranibizumab 0.5 mg :
• Endophthalmitis – 1.4 %
• Uveitis – 0.7%
• There was no increase in systemic adverse
effects such as HTN, arterial
thromboembolism in either study
24
25. DRUG COSTS :
• DRUG COSTS:
• Bevacizumab $ 45.00
• Ranibizumab $1594.92
25
26. Avastin vs. Lucentis
• The primary pharmacokinetic difference between
intraocular Bevacizumab and Ranibizumab is the very large
difference in systemic half-lives, i.e. 2 hours for
Ranibizumab versus 20 days for Bevacizumab.
• Since Bevacizumab was designed as a cancer treatment, the
long systemic half-life is considered to be a positive feature
(allowing greater exposure time of the tumor to the drug),
while the same long half-life is a negative feature in
intraocular treatment, since it has no benefit outside of the
eye and may in fact be detrimental.
• Although the systemic exposure with both drugs is very low,
Ranibizumab has a much lower average systemic exposure ,
so it may be has lesser chance of systemic adverse events.
26
27. Avastin vs. Lucentis
• The National Eye Institute (NEI) of the National Institutes of Health (NIH)
announced in October 2006 that it would fund a comparative study trial of
ranibizumab (Lucentis) and bevacizumab (Avastin) to assess the relative
safety and effectiveness in treating AMD.
• This study, called the Comparison of Age-Related Macular Degeneration
Treatment Trials (CATT Study), enrolled about 1,200 patients with newly
diagnosed wet AMD, randomly assigning the patients to one of four
treatment groups.The CATT Study was conducted at 47 clinical sites
throughout the United States, following the patients for 2 years.
• Initial results of the study showing essentially similar outcomes using
either drug at one year were formally published after peer review in the
New England Journal of Medicine on May 19, 2011.
• Similar results in this cohort were maintained at two years, with
bevacizumab showing no inferiority to ranibizumab, although a
statistically non-significant trend to improved visual outcomes from
injections given monthly rather than as required was noted with both
drugs
27
28. Avastin vs lucentis
• But, this same study(CATT) raised concerns that Avastin was NOT as safe
at Lucentis. The study showed a “number needed to harm” of 12 in favor
of Lucentis. What this means is that for every 12 patients treated with
Avastin instead of Lucentis, 1 would develop a bad systemic outcome. And
that is a pretty scary number.
Here at Queen’s University, we studied more than 1,500 of our patients
who received either drug. We found that patients who got an eye injection
with Avastin were 12 times more likely to develop serious inflammation
in the eye.
• We also noticed a trend towards the possibility of patients developing a
stroke within 30 days of getting an eye injection with Avastin. In our(CATT)
study this was NOT statistically significant but this concern was also
noted in a large study of over 40,000 patients in the US which showed a
22% higher risk of stroke for those using Avastin. These are significant
results.
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29. Anti-VEGF side effects
• Side effects:
• The most common side effects in clinical trials were
conjunctival hemorrhage, eye pain, vitreous floaters,
increased intraocular pressure, and intraocular inflammation.
• Although there is a theoretical risk for arterial
thromboembolic events in patients receiving VEGF-inhibitors
by intravitreal injection, the observed incidence rate was low
(< 4%) and similar to that seen in patients randomized to
placebo.(althought lesser also in ranibizumab)
• Serious adverse events related to the injection procedure
occurred with an incidence rate of less than 1% and included
endophthalmitis, retinal detachment, and traumatic cataracts.
29
30. Elevated I.O.P
• In conclusion, Hoang and colleagues' study provides more
evidence for potential sustained ocular hypertension after
repeated anti-VEGF injections. Although it seems logical
that this is more likely to occur in patients with preexisting
glaucoma, this study did not find such a correlation;
therefore, all patients should be monitored.
• Moreover, it is unclear whether the risk is the same with
ranibizumab and bevacizumab, but sustained ocular
hypertension can occur with either agent. Therefore,
ophthalmologists -- especially those who administer these
agents -- should be aware of this potential side effect and
be ready to treat it accordingly.
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31. Eylea(Aflibercept)
• Eylea (aflibercept, Regeneron) just received FDA
approval for treatment of Wet Macular
Degeneration.(BAYER)
• Eylea works by a similar mechanism as Lucentis
and Avastin (blocks Vascular Endothelial Growth
Factor or VEGF). Instead of being an antibody to
the VEGF molecule, it is a fusion protein
consisting of portions of the receptors for the
VEGF molecule (VEGFR-1, VEGFR-2), thereby
binding and blocking VEGF.
31
32. Eylea(Aflibercept) Indications
• EYLEA is indicated for the treatment of
patients with:
• Neovascular (Wet) Age-Related Macular
Degeneration (AMD)
• Macular Edema Following Central Retinal
Vein Occlusion (CRVO)
32
33. Eylea(Aflibercept) Indications
• Neovascular (Wet) Age-Related Macular
Degeneration (AMD)
• The recommended dose for EYLEA is 2 mg
(0.05 mL or 50 microliters) administered by
intravitreal injection every 4 weeks (monthly)
for the first 12 weeks (3 months), followed by
2 mg (0.05 mL) via intravitreal injection once
every 8 weeks (2 months).
33
34. Eylea(Aflibercept) Indications
• Macular Edema Following Central Retinal
Vein Occlusion (CRVO)
• The recommended dose for EYLEA is 2 mg
(0.05 mL or 50 microliters) administered by
intravitreal injection once every 4 weeks
(monthly
34
35. Eylea(Aflibercept)
• BOTTOM LINE: Eylea is a new drug mainly
for Wet AMD that may be helpful in patients
that do not completely respond to Lucentis
and Avastin. It has the potential of lasting
effect longer than Lucentis and Avastin, but
so far the evidence is not terribly strong and
the visual acuity results are not different.
35