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A randomised, double-masked phase III/IV study of the efficacy and safety of Avastin? (Bevacizumab) intravitreal injections compared to standard therapy in subjects with choroidal neovascularisation secondary to age-related macular degeneration: clinical trial design
Praveen J Patel, Catey Bunce, Adnan Tufail, the ABC Trial Investigators
Trials , 2008, DOI: 10.1186/1745-6215-9-56
Abstract: The Avastin? (bevacizumab) for choroidal neovascularisation (ABC) trial is a double-masked randomised controlled trial comparing intravitreal bevacizumab injections to standard therapy in the treatment of nAMD. Patients are randomised to intravitreal bevacizumab or standard therapy available at the time of trial initiation (verteporfin photodynamic therapy, intravitreal pegaptanib or sham treatment). Ranibizumab treatment was not included in the control arm as it had not been licensed for use at the start of recruitment for this trial. The primary outcome is the proportion of patients gaining ≥ 15 letters of visual acuity at 1 year and secondary outcomes include the proportion of patients with stable vision and mean visual acuity change.The ABC Trial is the first double-masked randomised control trial to investigate the efficacy and safety of intravitreal bevacizumab in the treatment of nAMD. This trial fully recruited in November 2007 and results should be available in early 2009. Important design issues for this clinical trial include (a) defining the control group (b) use of gain in vision as primary efficacy end-point and (c) use of pro re nata treatment using intravitreal bevacizumab rather than continuous therapy.Current controlled trials ISRCTN83325075Age-related macular degeneration (AMD) is the leading cause of visual loss in patients over the age of 50 years in Europe and North America [1]. There are 2 forms of the disease with dry AMD and wet AMD (neovascular or exudative AMD). Neovascular age-related macular degeneration (nAMD) is characterised by choroidal neovascularisation (CNV) and is responsible for 75% of visual loss due to AMD despite only accounting for 25% of all cases [2].Historically the prognosis for patients with subfoveal nAMD has been poor with the established treatment of verteporfin photodynamic therapy (PDT) only showing modest efficacy in reducing visual loss in patients with well-defined (predominantly classic or classic no occult) su
Effect of Intravitreal Ranibizumab in the Treatment of Peripapillary Choroidal Neovascularisation  [PDF]
Hassan Hamoudi,Torben Lykke S?rensen
Journal of Ophthalmology , 2011, DOI: 10.1155/2011/602729
Abstract: Intravitreal ranibizumab therapy is widely used in treatment of subfoveal choroidal neovascularisation (CNV) in age-related macular degeneration. We wanted to study the effect of intravitreal ranibizumab therapy in peripapillary CNV. A prospective recording of treatment outcomes in twelve eyes (12 patients) with peripapillary CNV with intravitreal injections of ranibizumab was performed. The patients received a series of 3 injections 4–6 weeks apart, and then a new ophthalmic examination was made including OCT and further therapy was given if the peripapillary CNV was still active. Nine patients had idiopathic peripapillary CNV, and in 3 patients it was associated to age-related macular degeneration. Followup had to be at least 6 months. The mean follow-up time was 15.9 (range 9–27) months and the mean number of injections 6.2 (3–10). In 10 patients treatment had resulted in an inactivation of the peripapillary CNV, but 3 of them had reactivation, while 2 patients had no inactivation. Currently, 5 patients are continuous to receive treatment. VA improved in 10 patients. Intravitreal ranibizumab therapy appears to be effective in patients with peripapillary CNV, but in some cases there is repeated reactivation or continuous activity of the peripapillary CNV. 1. Introduction The use of antivascular endothelial growth factor (anti-VEGF) agents for the treatment of retinal diseases is constantly increasing. Anti-VEGF was primarily introduced for the treatment of age-related macular degeneration (AMD) complicated with a sub- or juxtafoveal choroidal neovascularisation, but its use is now expanding to retinal vein occlusions and diabetic macular edema [1–3]. Peripapillary CNV is rare. Several conditions can cause peripapillary CNV including AMD (the most common cause, 45.2% of the cases), idiopathic (39.1%), multifocal choroiditis (4.3%), angioid streaks (2.6%), histoplasmosis (1.7%), choroidal osteoma (1.7%), optic disc drusen (0.9%), and congenital disc anomaly (0.9%) and has been reported in sarcoid [4]. No randomised or large study has evaluated the efficacy of anti-VEGF on peripapillary CNV hence standard care for peripapillary CNV remains argon laser photocoagulation or photodynamic therapy [5, 6]. However, since anti-VEGF is effective in treating CNV, it seems relevant to treat peripapillary CNV with anti-VEGF. Information regarding the efficacy of anti-VEGF on peripapillary CNV is based on case reports and small case series [7–12]. Overall the results suggest a possible beneficial effect of anti-VEGF on peripapillary CNV, but questions remain
Effect of Intravitreal Ranibizumab in the Treatment of Peripapillary Choroidal Neovascularisation  [PDF]
Hassan Hamoudi,Torben Lykke S rensen
Journal of Ophthalmology , 2011, DOI: 10.1155/2011/602729
Abstract: Intravitreal ranibizumab therapy is widely used in treatment of subfoveal choroidal neovascularisation (CNV) in age-related macular degeneration. We wanted to study the effect of intravitreal ranibizumab therapy in peripapillary CNV. A prospective recording of treatment outcomes in twelve eyes (12 patients) with peripapillary CNV with intravitreal injections of ranibizumab was performed. The patients received a series of 3 injections 4–6 weeks apart, and then a new ophthalmic examination was made including OCT and further therapy was given if the peripapillary CNV was still active. Nine patients had idiopathic peripapillary CNV, and in 3 patients it was associated to age-related macular degeneration. Followup had to be at least 6 months. The mean follow-up time was 15.9 (range 9–27) months and the mean number of injections 6.2 (3–10). In 10 patients treatment had resulted in an inactivation of the peripapillary CNV, but 3 of them had reactivation, while 2 patients had no inactivation. Currently, 5 patients are continuous to receive treatment. VA improved in 10 patients. Intravitreal ranibizumab therapy appears to be effective in patients with peripapillary CNV, but in some cases there is repeated reactivation or continuous activity of the peripapillary CNV.
Lasting Controversy on Ranibizumab and Bevacizumab
Lihui Zou, Huiying Lai, Qi Zhou, Fei Xiao
Theranostics , 2011,
Abstract: Vascular endothelial growth factor (VEGF), an important angiogenic factor that is able to stimulate the proliferation and migration of endothelial cells, is the best-studied hallmark of angiogenesis. Neovascularization is a major cause of age-related macular degeneration (AMD) which is a leading cause of blindness in the elderly population. Specific molecular inhibitors of VEGF have been proved to be useful in the treatment of AMD. Ranibizumab and Bevacizumab are structurally similar to anti-VEGF drugs in the treatment of AMD. Many studies have indicated that Ranibizumab and Bevacizumab are of roughly equal short-term efficacy and safety, Bevacizumab is an attractive alternative to Ranibizumab due to its lower cost. However, only Ranibizumab has received Food and Drug Administration (FDA) approval for the treatment of macular degeneration. More multicenter clinical trials are required to compare the relative efficacy and safety of these two drugs and some progress has been achieved. This review discusses the clinical effectiveness, safety, cost and other practical implications of Ranibizumab and Bevacizumab.
Acute anterior uveitis following intravitreal bevacizumab but not subsequent ranibizumab  [cached]
Antonopoulos C,Stem M,Comer GM
Clinical Ophthalmology , 2011,
Abstract: Christina Antonopoulos1, Maxwell Stem2, Grant M Comer21Department of Ophthalmology, Boston University, Boston, MA, USA; 2WK Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, MI, USAPurpose: Previous reports have identified noninfectious uveitis as a potential sequela following both intravitreal bevacizumab and ranibizumab injections. We present two unique cases of acute anterior uveitis following intravitreal bevacizumab that did not occur with subsequent ranibizumab injections.Methods: Case report.Conclusion: These cases may reflect differences in the etiology of anterior uveitis following intravitreal bevacizumab and ranibizumab. Given these differences, it may be reasonable to offer ranibizumab to patients who have experienced presumed bevacizumab-induced anterior uveitis.Keywords: adverse effect, age-related macular degeneration, anterior uveitis, bevacizumab, ranibizumab, uveitis
Comparative study of 1+PRN ranibizumab versus bevacizumab in the clinical setting  [cached]
Carneiro AM,Mendonça LS,Falcão MS,Fonseca SL
Clinical Ophthalmology , 2012,
Abstract: Angela M Carneiro,1,2 Luis S Mendon a,1 Manuel S Falc o,1,2 Sofia L Fonseca,1 Elisete M Brand o,1 Fernando M Falc o-Reis1,21Department of Ophthalmology of Hospital de S o Jo o, Porto, Portugal; 2Faculty of Medicine of University of Porto, Porto, PortugalPurpose: We compared the efficacy of intravitreal ranibizumab and bevacizumab for treating neovascular age-related macular degeneration using an on-demand regimen.Methods: A total of 186 wet age-related macular degeneration eyes of 186 treatment-na ve patients were compared retrospectively (67 eyes treated with ranibizumab with 91 treated with bevacizumab). At baseline, mean age, best corrected visual acuity, and angiographic lesion types were similar in both groups. Best corrected visual acuity and ocular coherence tomography were evaluated.Results: Sixty eyes treated with ranibizumab and 85 eyes treated with bevacizumab completed a 12-month evaluation. At 12 months, mean best corrected visual acuity increased by +6.65 letters with ranibizumab treatment and by +5.59 with bevacizumab treatment (P = 0.64). Visual acuity improved by ≥15 letters in 15 eyes treated with ranibizumab and in 21 eyes treated with bevacizumab (P = 0.75). An overall reduction in ocular coherence tomography central thickness occurred for all time points. The mean number of injections per eye was 5.97 with ranibizumab and 5.92 with bevacizumab (P = 0.90).Conclusion: Intravitreal therapies with ranibizumab or bevacizumab have similar visual and anatomical results. These results confirm those of comparison of Age-Related Macular Degeneration Treatment Trials in as-needed cohorts in clinical practice. Randomized long-term clinical trials are necessary to examine the systemic safety of these treatments.Keywords: AMD, anti-VEGF therapy, bevacizumab, choroidal neovascularization, ranibizumab, wet AMD
Acute anterior uveitis following intravitreal bevacizumab but not subsequent ranibizumab
Antonopoulos C, Stem M, Comer GM
Clinical Ophthalmology , 2011, DOI: http://dx.doi.org/10.2147/OPTH.S26880
Abstract: cute anterior uveitis following intravitreal bevacizumab but not subsequent ranibizumab Case report (2697) Total Article Views Authors: Antonopoulos C, Stem M, Comer GM Published Date November 2011 Volume 2011:5 Pages 1659 - 1662 DOI: http://dx.doi.org/10.2147/OPTH.S26880 Christina Antonopoulos1, Maxwell Stem2, Grant M Comer2 1Department of Ophthalmology, Boston University, Boston, MA, USA; 2WK Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, MI, USA Purpose: Previous reports have identified noninfectious uveitis as a potential sequela following both intravitreal bevacizumab and ranibizumab injections. We present two unique cases of acute anterior uveitis following intravitreal bevacizumab that did not occur with subsequent ranibizumab injections. Methods: Case report. Conclusion: These cases may reflect differences in the etiology of anterior uveitis following intravitreal bevacizumab and ranibizumab. Given these differences, it may be reasonable to offer ranibizumab to patients who have experienced presumed bevacizumab-induced anterior uveitis.
Changing from bevacizumab to ranibizumab in age-related macular degeneration. Is it safe?  [cached]
Dimitrios A Karagiannis,Ioannis D Ladas,Efstratios Parikakis
Clinical Interventions in Aging , 2009,
Abstract: Dimitrios A Karagiannis1, Ioannis D Ladas2, Efstratios Parikakis1, Ilias Georgalas2, Athanasios Kotsolis2, Giorgos Amariotakis1, Vasileios Soumplis1, Panagiotis Mitropoulos11Ophthalmiatrio Eye Hospital of Athens, Athens, Greece; 2First Department of Ophthalmology, Medical School of Athens University, General Hospital of Athens, Athens, GreeceObjective: To report our experiences in changing from intravitreal bevacizumab to ranibizumab in age-related macular degeneration (AMD).Design: Retrospective case series.Participants and methods: We retrospectively reviewed the records of 34 patients (36 eyes) who were treated with monthly injections of intravitreal bevacizumab for six months and then switched to monthly injections of ranibizumab for 12 months. Best-corrected visual acuity measurements (BCVA), contact lens biomicroscopy, optical coherence tomography (OCT), and fluorescein angiography were performed at the baseline examination and then monthly. Chi-square test was used for statistical analysis.Results: Following bevacizumab treatment, retinal thickness decreased (P = 0.033) while BCVA improved (P = 0.040). Changing from bevacizumab to ranibizumab resulted in a transient decrease in BCVA (P = 0.045) and an increase in retinal thickness (P = 0.042). In addition, three eyes presented with a large subretinal hemorrhage. However, final retinal thickness was better than the initial thickness and the value following the bevacizumab course. No major ocular or systemic side effects were noted.Conclusions: Ranibizumab was clinically effective in the long term but the change of treatment from bevacizumab to a half-size molecule with less half-life in the vitreous such as ranibizumab contributed to a transient “instability” in the eye which may have triggered the large subretinal hemorrhage. There is insufficient experience reported in the literature in switching from one agent to another. A prospective study with controls is necessary to determine whether it is safe to change from one medication to another.Keywords: age-related macular degeneration, bevacizumab, ranibizumab, subretinal hemorrhage
Comparative study of 1+PRN ranibizumab versus bevacizumab in the clinical setting
Carneiro AM, Mendon a LS, Falc o MS, Fonseca SL, Brand o EM, Falc o-Reis FM
Clinical Ophthalmology , 2012, DOI: http://dx.doi.org/10.2147/OPTH.S33017
Abstract: mparative study of 1+PRN ranibizumab versus bevacizumab in the clinical setting Original Research (1449) Total Article Views Authors: Carneiro AM, Mendon a LS, Falc o MS, Fonseca SL, Brand o EM, Falc o-Reis FM Published Date July 2012 Volume 2012:6 Pages 1149 - 1157 DOI: http://dx.doi.org/10.2147/OPTH.S33017 Received: 16 April 2012 Accepted: 05 June 2012 Published: 19 July 2012 Angela M Carneiro,1,2 Luis S Mendon a,1 Manuel S Falc o,1,2 Sofia L Fonseca,1 Elisete M Brand o,1 Fernando M Falc o-Reis1,2 1Department of Ophthalmology of Hospital de S o Jo o, Porto, Portugal; 2Faculty of Medicine of University of Porto, Porto, Portugal Purpose: We compared the efficacy of intravitreal ranibizumab and bevacizumab for treating neovascular age-related macular degeneration using an on-demand regimen. Methods: A total of 186 wet age-related macular degeneration eyes of 186 treatment-na ve patients were compared retrospectively (67 eyes treated with ranibizumab with 91 treated with bevacizumab). At baseline, mean age, best corrected visual acuity, and angiographic lesion types were similar in both groups. Best corrected visual acuity and ocular coherence tomography were evaluated. Results: Sixty eyes treated with ranibizumab and 85 eyes treated with bevacizumab completed a 12-month evaluation. At 12 months, mean best corrected visual acuity increased by +6.65 letters with ranibizumab treatment and by +5.59 with bevacizumab treatment (P = 0.64). Visual acuity improved by ≥15 letters in 15 eyes treated with ranibizumab and in 21 eyes treated with bevacizumab (P = 0.75). An overall reduction in ocular coherence tomography central thickness occurred for all time points. The mean number of injections per eye was 5.97 with ranibizumab and 5.92 with bevacizumab (P = 0.90). Conclusion: Intravitreal therapies with ranibizumab or bevacizumab have similar visual and anatomical results. These results confirm those of comparison of Age-Related Macular Degeneration Treatment Trials in as-needed cohorts in clinical practice. Randomized long-term clinical trials are necessary to examine the systemic safety of these treatments.
Changing from bevacizumab to ranibizumab in age-related macular degeneration. Is it safe?
Dimitrios A Karagiannis, Ioannis D Ladas, Efstratios Parikakis, et al.
Clinical Interventions in Aging , 2009, DOI: http://dx.doi.org/10.2147/CIA.S8367
Abstract: nging from bevacizumab to ranibizumab in age-related macular degeneration. Is it safe? Original Research (4974) Total Article Views Authors: Dimitrios A Karagiannis, Ioannis D Ladas, Efstratios Parikakis, et al. Published Date November 2009 Volume 2009:4 Pages 457 - 461 DOI: http://dx.doi.org/10.2147/CIA.S8367 Dimitrios A Karagiannis1, Ioannis D Ladas2, Efstratios Parikakis1, Ilias Georgalas2, Athanasios Kotsolis2, Giorgos Amariotakis1, Vasileios Soumplis1, Panagiotis Mitropoulos1 1Ophthalmiatrio Eye Hospital of Athens, Athens, Greece; 2First Department of Ophthalmology, Medical School of Athens University, General Hospital of Athens, Athens, Greece Objective: To report our experiences in changing from intravitreal bevacizumab to ranibizumab in age-related macular degeneration (AMD). Design: Retrospective case series. Participants and methods: We retrospectively reviewed the records of 34 patients (36 eyes) who were treated with monthly injections of intravitreal bevacizumab for six months and then switched to monthly injections of ranibizumab for 12 months. Best-corrected visual acuity measurements (BCVA), contact lens biomicroscopy, optical coherence tomography (OCT), and fluorescein angiography were performed at the baseline examination and then monthly. Chi-square test was used for statistical analysis. Results: Following bevacizumab treatment, retinal thickness decreased (P = 0.033) while BCVA improved (P = 0.040). Changing from bevacizumab to ranibizumab resulted in a transient decrease in BCVA (P = 0.045) and an increase in retinal thickness (P = 0.042). In addition, three eyes presented with a large subretinal hemorrhage. However, final retinal thickness was better than the initial thickness and the value following the bevacizumab course. No major ocular or systemic side effects were noted. Conclusions: Ranibizumab was clinically effective in the long term but the change of treatment from bevacizumab to a half-size molecule with less half-life in the vitreous such as ranibizumab contributed to a transient “instability” in the eye which may have triggered the large subretinal hemorrhage. There is insufficient experience reported in the literature in switching from one agent to another. A prospective study with controls is necessary to determine whether it is safe to change from one medication to another.
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