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Bevasiranib for the Treatment of Wet, Age-Related Macular Degeneration
Adinoyi O. Garba and Shaker A. Mousa
Ophthalmology and Eye Diseases , 2012, DOI: 10.4137/OED.S4878
Abstract: Age- related Macular Degeneration (AMD) is the leading cause of severe visual impairment in people 65 years and older in industrialized nations. Exudative, or “wet”, AMD is a late form of AMD (as distinguished from atrophic, so-called dry, AMD) and is responsible for over 60% of all cases of blindness due to AMD. It is widely accepted that vascular endothelial growth factor (VEGF) is a key component in the pathogenesis of choroidal neo-vascularization (CNV), which is a precursor to wet AMD. The current gold-standard for treating wet AMD is the monoclonal antibody fragment ranibizumab (trade name Lucentis), which targets VEGF. Other agents used to treat wet AMD include pegaptanib (Macugen), bevacizumab (Avastin; off-label use), and several other experimental agents. The advent of small interfering RNA (siRNA) has presented a whole new approach to inhibiting VEGF. This article reviews the status of a novel siRNA-based therapeutic, bevasiranib, for the treatment of wet AMD. Bevasiranib is believed to work by down regulating VEGF production in the retina. Studies in human cell-lines and animal models have shown that VEGF siRNAs are effective in inhibiting VEGF production. Although there is a lack of sufficient published data on human studies supporting the use of bevasiranib for wet AMD, available data indicates that due to its unique mechanism of action, bevasiranib might hold some promise as a primary or adjunct treatment for wet AMD.
Spectral domain OCT versus time domain OCT in the evaluation of macular features related to wet age-related macular degeneration  [cached]
Pierro L,Zampedri E,Milani P,Gagliardi M
Clinical Ophthalmology , 2012,
Abstract: Luisa Pierro1, Elena Zampedri1, Paolo Milani2, Marco Gagliardi1, Vincenzo Isola2, Alfredo Pece21Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy, 2Fondazione Retina 3000, Milano, ItalyBackground: The aim of this study was to compare the agreement between spectral domain optical coherence tomography (SD OCT) and time domain stratus OCT (TD OCT) in evaluating macular morphology alterations in wet age-related macular degeneration (AMD).Methods: This retrospective study was performed on 77 eyes of 77 patients with primary or recurring subfoveal choroidal neovascularization secondary to AMD. All patients underwent OCT examination using Zeiss Stratus OCT 3 (Carl Zeiss Meditec Inc, Dublin, CA) and Opko OTI Spectral SLO/OCT (Ophthalmic Technologies Inc, Toronto, Canada). In all radial line scans, the presence of intraretinal edema (IRE), serous pigment epithelium detachment (sPED), neurosensory serous retinal detachment (NSRD), epiretinal membrane (EM), inner limiting membrane thickening (ILMT), and hard exudates (HE) were evaluated. The degree of matching was quantified by Kappa measure of agreement.Results: The percentage distribution of TD OCT findings versus SD OCT findings was: IRE 36.3% versus 77.9%, sPED 57.1% versus 85.7%, NSRD 38.9% versus 53.2%, EM 10.5% versus 26.3%, ILMT 3.8% versus 32.4%, and HE 6.4% versus 54.5%. The agreement was as follows: sPED: kappa value 0.15; NSRD: kappa value 0.61; IRE: kappa value 0.18; EM: kappa value 0.41; ILMT: kappa value 0.02; HE: kappa value 0.06.Conclusion: The agreement in the evaluation of macular lesions between the two techniques is poor and depends on the lesion considered. SD OCT allows better detection of the alterations typically related to choroidal neovascularization such as IRE, PED, ILM thickening, and HE. Consequently its use should be strongly considered in patients with wet AMD.Keywords: spectral domain, OCT, time domain, macular degeneration, AMD
Profile of ranibizumab: efficacy and safety for the treatment of wet age-related macular degeneration
Chen Y,Han F
Therapeutics and Clinical Risk Management , 2012,
Abstract: Youxin Chen, Fei HanDepartment of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, ChinaAbstract: Wet age-related macular degeneration (AMD) causes severe vision loss due to the development of choroidal neovascularization (CNV). The critical role of vascular endothelial growth factor in the pathogenesis of CNV is well understood. Ranibizumab plays an inhibitory role with CNV and reduces vascular permeability by binding to vascular endothelial growth factor. Intravitreal ranibizumab reduces the risk of visual acuity (VA) loss and increases the chance of VA gain compared with no treatment or photodynamic therapy for CNV in AMD. Some high-quality research has shown that the optimal timing for ranibizumab treating wet AMD is the first 3 months. It is recommended that ranibizumab is intravitreally injected monthly in the initiation for at least 3 months. Subsequent managing of regimens should be made dependent on the VA change, fundus examination, and image of optical coherence topography. An individualized strategy or combined method with photodynamic therapy is beneficial to the active lesion in the consecutive treatment of ranibizumab for CNV, and may be a good choice in order to decrease injection times. Regarding the safety profile, ranibizumab has been well tolerated in clinical trials. The principal ocular adverse event detected in clinical trials is a low frequency of ocular inflammation. Key serious ocular adverse events occurred in <5% of ranibizumab-treated patients in large-scale clinical trials. It appears unlikely that treatment with ranibizumab increases the risk of vascular events significantly. Less frequent injections on an as-needed schedule, based on monthly monitoring may have the most optimal risk:benefit ratio.Keywords: age-related macular degeneration, choroidal neovascularization, ranibizumab, efficacy, safety
Spectral domain OCT versus time domain OCT in the evaluation of macular features related to wet age-related macular degeneration
Pierro L, Zampedri E, Milani P, Gagliardi M, Isola V, Pece A
Clinical Ophthalmology , 2012, DOI: http://dx.doi.org/10.2147/OPTH.S27656
Abstract: tral domain OCT versus time domain OCT in the evaluation of macular features related to wet age-related macular degeneration Original Research (3342) Total Article Views Authors: Pierro L, Zampedri E, Milani P, Gagliardi M, Isola V, Pece A Published Date February 2012 Volume 2012:6 Pages 219 - 223 DOI: http://dx.doi.org/10.2147/OPTH.S27656 Received: 25 October 2011 Accepted: 28 November 2011 Published: 10 February 2012 Luisa Pierro1, Elena Zampedri1, Paolo Milani2, Marco Gagliardi1, Vincenzo Isola2, Alfredo Pece2 1Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy, 2Fondazione Retina 3000, Milano, Italy Background: The aim of this study was to compare the agreement between spectral domain optical coherence tomography (SD OCT) and time domain stratus OCT (TD OCT) in evaluating macular morphology alterations in wet age-related macular degeneration (AMD). Methods: This retrospective study was performed on 77 eyes of 77 patients with primary or recurring subfoveal choroidal neovascularization secondary to AMD. All patients underwent OCT examination using Zeiss Stratus OCT 3 (Carl Zeiss Meditec Inc, Dublin, CA) and Opko OTI Spectral SLO/OCT (Ophthalmic Technologies Inc, Toronto, Canada). In all radial line scans, the presence of intraretinal edema (IRE), serous pigment epithelium detachment (sPED), neurosensory serous retinal detachment (NSRD), epiretinal membrane (EM), inner limiting membrane thickening (ILMT), and hard exudates (HE) were evaluated. The degree of matching was quantified by Kappa measure of agreement. Results: The percentage distribution of TD OCT findings versus SD OCT findings was: IRE 36.3% versus 77.9%, sPED 57.1% versus 85.7%, NSRD 38.9% versus 53.2%, EM 10.5% versus 26.3%, ILMT 3.8% versus 32.4%, and HE 6.4% versus 54.5%. The agreement was as follows: sPED: kappa value 0.15; NSRD: kappa value 0.61; IRE: kappa value 0.18; EM: kappa value 0.41; ILMT: kappa value 0.02; HE: kappa value 0.06. Conclusion: The agreement in the evaluation of macular lesions between the two techniques is poor and depends on the lesion considered. SD OCT allows better detection of the alterations typically related to choroidal neovascularization such as IRE, PED, ILM thickening, and HE. Consequently its use should be strongly considered in patients with wet AMD.
Profile of ranibizumab: efficacy and safety for the treatment of wet age-related macular degeneration
Chen Y, Han F
Therapeutics and Clinical Risk Management , 2012, DOI: http://dx.doi.org/10.2147/TCRM.S32801
Abstract: ofile of ranibizumab: efficacy and safety for the treatment of wet age-related macular degeneration Review (1473) Total Article Views Authors: Chen Y, Han F Published Date July 2012 Volume 2012:8 Pages 343 - 351 DOI: http://dx.doi.org/10.2147/TCRM.S32801 Received: 10 April 2012 Accepted: 14 May 2012 Published: 11 July 2012 Youxin Chen, Fei Han Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China Abstract: Wet age-related macular degeneration (AMD) causes severe vision loss due to the development of choroidal neovascularization (CNV). The critical role of vascular endothelial growth factor in the pathogenesis of CNV is well understood. Ranibizumab plays an inhibitory role with CNV and reduces vascular permeability by binding to vascular endothelial growth factor. Intravitreal ranibizumab reduces the risk of visual acuity (VA) loss and increases the chance of VA gain compared with no treatment or photodynamic therapy for CNV in AMD. Some high-quality research has shown that the optimal timing for ranibizumab treating wet AMD is the first 3 months. It is recommended that ranibizumab is intravitreally injected monthly in the initiation for at least 3 months. Subsequent managing of regimens should be made dependent on the VA change, fundus examination, and image of optical coherence topography. An individualized strategy or combined method with photodynamic therapy is beneficial to the active lesion in the consecutive treatment of ranibizumab for CNV, and may be a good choice in order to decrease injection times. Regarding the safety profile, ranibizumab has been well tolerated in clinical trials. The principal ocular adverse event detected in clinical trials is a low frequency of ocular inflammation. Key serious ocular adverse events occurred in <5% of ranibizumab-treated patients in large-scale clinical trials. It appears unlikely that treatment with ranibizumab increases the risk of vascular events significantly. Less frequent injections on an as-needed schedule, based on monthly monitoring may have the most optimal risk:benefit ratio.
Clinical and differential utility of VEGF inhibitors in wet age-related macular degeneration: focus on aflibercept
Stewart MW
Clinical Ophthalmology , 2012, DOI: http://dx.doi.org/10.2147/OPTH.S33372
Abstract: ical and differential utility of VEGF inhibitors in wet age-related macular degeneration: focus on aflibercept Review (2969) Total Article Views Authors: Stewart MW Published Date July 2012 Volume 2012:6 Pages 1175 - 1186 DOI: http://dx.doi.org/10.2147/OPTH.S33372 Received: 27 April 2012 Accepted: 18 May 2012 Published: 26 July 2012 Michael W Stewart College of Medicine, Mayo Clinic, Jacksonville, FL, USA Abstract: Age-related macular degeneration (AMD) has become a major public health problem and a leading cause of blindness in industrialized nations. AMD results from the ageing eye's inability to metabolize and dispose completely of photoreceptor outer segments and other waste products. As a result, lipids, particularly apolipoproteins, accumulate within Bruch's membrane, leading to chronic ischemia and inflammation. The subsequent upregulation of inflammatory cytokines and growth factors, including vascular endothelial growth factor (VEGF), induces the growth of neovascular membranes from the choriocapillaris into the subretinal or subretinal pigment epithelium spaces. To counter this, intravitreally administered drugs (pegaptanib, bevacizumab, ranibizumab) that specifically target VEGF have become the standard treatment for exudative AMD. Aflibercept, a recently approved fusion protein, binds to all isoforms of both VEGF-A and placental growth factor with high affinity. Phase III trials showed that monthly or every other month injections of aflibercept prevent vision loss (fewer than 15 letters) in 95% of patients. Additionally, aflibercept injections every 4 or 8 weeks produce average vision gains of 6.9 letters to 10.9 letters, comparable with those achieved with monthly ranibizumab. After one year of regularly administered aflibercept injections, patients required an average of only 4.2 injections during the second year. Aflibercept promises to decrease the injection frequency required for many patients and appears to serve as an effective “salvage” therapy for patients who respond poorly to other anti-VEGF drugs.
Patients’ knowledge and perspectives on wet age-related macular degeneration and its treatment
Sushma Kandula, Jeffrey C Lamkin, Teresa Albanese, et al
Clinical Ophthalmology , 2010, DOI: http://dx.doi.org/10.2147/OPTH.S9969
Abstract: tients’ knowledge and perspectives on wet age-related macular degeneration and its treatment Original Research (4377) Total Article Views Authors: Sushma Kandula, Jeffrey C Lamkin, Teresa Albanese, et al Published Date April 2010 Volume 2010:4 Pages 375 - 381 DOI: http://dx.doi.org/10.2147/OPTH.S9969 Sushma Kandula1, Jeffrey C Lamkin1, Teresa Albanese2, Deepak P Edward1 1Department of Ophthalmology, 2Health Service Research and Education Institute, SUMMA Health System, Akron OH, USA Summary: There have been no studies examining the level of understanding age-related macular degeneration (ARMD) patients have about their disease, or their perceptions about intraocular injections as treatment. In this study, patient knowledge about ARMD risk factors was low but patients appeared more optimistic than fearful when confronted with intraocular antivascular endothelial growth factor (anti-VEGF) injections as treatment. Purpose: In recent years there has been an increase in our understanding of wet ARMD, and a dramatic shift in the treatment paradigm. However, to our knowledge, no studies have examined how much ARMD patients understand their disease, or how they feel about receiving intraocular injections as treatment. The primary objectives of this study are to identify areas in which ARMD patients may be uninformed about their disease, and to recognize specific fears or expectations that patients may have regarding treatment with intraocular anti-VEGF injections. Design: Prospective, survey-based study. Methods: This is a prospective survey-based study. An anonymous 32-item questionnaire was compiled and distributed to patients with wet ARMD who underwent at least one intraocular anti-VEGF injection. Eighty-three patients from a retina practice in a suburban setting completed the questionnaire that gauged both their knowledge of ARMD and their perspectives on its treatment. Data was analyzed using chi-square testing. Results: Seventy-eight percent of patients received most of their knowledge of ARMD from their physician. Eighty-nine percent of patients prefer to receive more information on ARMD, if needed, directly from their physician. Only 21%, 48%, 37%, 48%, and 36%, respectively, correctly identified how diet, special vitamins, high blood pressure, family history, and smoking can affect ARMD. Sixty percent felt somewhat afraid or very afraid about getting their first intraocular injection but this did not correlate with pain or discomfort during treatment (P = 0.075, P = 0.117). Eighty-nine percent were very satisfied and 11% were somewhat satisfied with the explanation their physician gave them about the injections. Eighty percent reported feeling hopeful (significantly more than any other emotion) when they were first told they needed an intraocular injection for treatment of their disease. Conclusions: Knowledge of risk factors and risk factor modification among patients with ARMD is low. Since the vast majority of ARMD patients prefer to receive
Patients’ knowledge and perspectives on wet age-related macular degeneration and its treatment  [cached]
Sushma Kandula,Jeffrey C Lamkin,Teresa Albanese,et al
Clinical Ophthalmology , 2010,
Abstract: Sushma Kandula1, Jeffrey C Lamkin1, Teresa Albanese2, Deepak P Edward11Department of Ophthalmology, 2Health Service Research and Education Institute, SUMMA Health System, Akron OH, USASummary: There have been no studies examining the level of understanding age-related macular degeneration (ARMD) patients have about their disease, or their perceptions about intraocular injections as treatment. In this study, patient knowledge about ARMD risk factors was low but patients appeared more optimistic than fearful when confronted with intraocular antivascular endothelial growth factor (anti-VEGF) injections as treatment.Purpose: In recent years there has been an increase in our understanding of wet ARMD, and a dramatic shift in the treatment paradigm. However, to our knowledge, no studies have examined how much ARMD patients understand their disease, or how they feel about receiving intraocular injections as treatment. The primary objectives of this study are to identify areas in which ARMD patients may be uninformed about their disease, and to recognize specific fears or expectations that patients may have regarding treatment with intraocular anti-VEGF injections.Design: Prospective, survey-based study.Methods: This is a prospective survey-based study. An anonymous 32-item questionnaire was compiled and distributed to patients with wet ARMD who underwent at least one intraocular anti-VEGF injection. Eighty-three patients from a retina practice in a suburban setting completed the questionnaire that gauged both their knowledge of ARMD and their perspectives on its treatment. Data was analyzed using chi-square testing.Results: Seventy-eight percent of patients received most of their knowledge of ARMD from their physician. Eighty-nine percent of patients prefer to receive more information on ARMD, if needed, directly from their physician. Only 21%, 48%, 37%, 48%, and 36%, respectively, correctly identified how diet, special vitamins, high blood pressure, family history, and smoking can affect ARMD. Sixty percent felt somewhat afraid or very afraid about getting their first intraocular injection but this did not correlate with pain or discomfort during treatment (P = 0.075, P = 0.117). Eighty-nine percent were very satisfied and 11% were somewhat satisfied with the explanation their physician gave them about the injections. Eighty percent reported feeling hopeful (significantly more than any other emotion) when they were first told they needed an intraocular injection for treatment of their disease.Conclusions: Knowledge of risk factors and risk factor modification
Clinical and differential utility of VEGF inhibitors in wet age-related macular degeneration: focus on aflibercept  [cached]
Stewart MW
Clinical Ophthalmology , 2012,
Abstract: Michael W StewartCollege of Medicine, Mayo Clinic, Jacksonville, FL, USAAbstract: Age-related macular degeneration (AMD) has become a major public health problem and a leading cause of blindness in industrialized nations. AMD results from the ageing eye's inability to metabolize and dispose completely of photoreceptor outer segments and other waste products. As a result, lipids, particularly apolipoproteins, accumulate within Bruch's membrane, leading to chronic ischemia and inflammation. The subsequent upregulation of inflammatory cytokines and growth factors, including vascular endothelial growth factor (VEGF), induces the growth of neovascular membranes from the choriocapillaris into the subretinal or subretinal pigment epithelium spaces. To counter this, intravitreally administered drugs (pegaptanib, bevacizumab, ranibizumab) that specifically target VEGF have become the standard treatment for exudative AMD. Aflibercept, a recently approved fusion protein, binds to all isoforms of both VEGF-A and placental growth factor with high affinity. Phase III trials showed that monthly or every other month injections of aflibercept prevent vision loss (fewer than 15 letters) in 95% of patients. Additionally, aflibercept injections every 4 or 8 weeks produce average vision gains of 6.9 letters to 10.9 letters, comparable with those achieved with monthly ranibizumab. After one year of regularly administered aflibercept injections, patients required an average of only 4.2 injections during the second year. Aflibercept promises to decrease the injection frequency required for many patients and appears to serve as an effective “salvage” therapy for patients who respond poorly to other anti-VEGF drugs.Keywords: age-related macular degeneration, choroidal neovascularization, vascular endothelial growth factor, aflibercept, ranibizumab, bevacizumab, VEGF trap
A Common Complement C3 Variant Is Associated with Protection against Wet Age-Related Macular Degeneration in a Japanese Population  [PDF]
Suiho Yanagisawa, Naoshi Kondo, Akiko Miki, Wataru Matsumiya, Sentaro Kusuhara, Yasutomo Tsukahara, Shigeru Honda, Akira Negi
PLOS ONE , 2011, DOI: 10.1371/journal.pone.0028847
Abstract: Background Genetic variants in the complement component 3 gene (C3) have been shown to be associated with age-related macular degeneration (AMD) in Caucasian populations of European descent. In particular, a nonsynonymous coding variant, rs2230199 (R102G), is presumed to be the most likely causal variant in the C3 locus based on strong statistical evidence for disease association and mechanistic functional evidence. However, the risk allele is absent or rare (<1%) in Japanese and Chinese populations, and the association of R102G with AMD has not been reported in Asian populations. Genetic heterogeneity of disease-associated variants among different ethnicities is common in complex diseases. Here, we sought to examine whether other common variants in C3 are associated with wet AMD, a common advanced-stage manifestation of AMD, in a Japanese population. Methodology/Principal Findings We genotyped 13 tag single nucleotide polymorphisms (SNPs) that capture the majority of common variations in the C3 locus and tested for associations between these SNPs and wet AMD in a Japanese population comprising 420 case subjects and 197 controls. A noncoding variant in C3 (rs2241394) exhibited statistically significant evidence of association (allelic P = 8.32×10?4; odds ratio = 0.48 [95% CI = 0.31–0.74] for the rs2241394 C allele). Multilocus logistic regression analysis confirmed that the effect of rs2241394 was independent of the previously described loci at ARMS2 and CFH, and that the model including variants in ARMS2 and CFH plus C3 rs2241394 provided a better fit than the model without rs2241394. We found no evidence of epistasis between variants in C3 and CFH, despite the fact that they are involved in the same biological pathway. Conclusions Our study provides evidence that C3 is a common AMD-associated locus that transcends racial boundaries and provides an impetus for more detailed genetic characterization of the C3 locus in Asian populations.
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