Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study
Objective To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. Methods A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the...
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| Published in | British journal of ophthalmology Vol. 98; no. 11; pp. 1543 - 1546 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BMJ Publishing Group LTD
01.11.2014
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0007-1161 1468-2079 1468-2079 |
| DOI | 10.1136/bjophthalmol-2013-304075 |
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| Abstract | Objective To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. Methods A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory. Results Of 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery. Conclusions In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use. Trial registration number NCT00321997. |
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| AbstractList | To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation.OBJECTIVETo assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation.A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory.METHODSA posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory.Of 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery.RESULTSOf 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery.In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use.CONCLUSIONSIn V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use.NCT00321997.TRIAL REGISTRATION NUMBERNCT00321997. Objective To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. Methods A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory. Results Of 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery. Conclusions In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use. Trial registration number NCT00321997. To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory. Of 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery. In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use. NCT00321997. Objective To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. Methods A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory. Results Of 221 subjects, IOP measurements â[per thousand]¥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements â[per thousand]¥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements â[per thousand]¥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements â[per thousand]¥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery. Conclusions In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use. Trial registration number NCT00321997. |
| Author | Boyer, David S Goldbaum, Mauro Leys, Anita M Starita, Carla |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24997182$$D View this record in MEDLINE/PubMed |
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| Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. Copyright: 2014 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions |
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| DOI | 10.1136/bjophthalmol-2013-304075 |
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| Keywords | Neovascularisation Treatment Medical Intraocular Pressure Vision |
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| References | Good, Kimura, Mandava 2011; 95 Skalicky, Ho, Agar 2012; 43 Colton, Ederer 1980; 25 Wehrli, Tawse, Levin 2012; 32 Kahook, Ammar 2010; 19 Brown, Kaiser, Michels 2006; 355 Friberg, Tolentino, Weber 2010; 94 D'Amico, Masonson, Patel 2006; 113 Rosenfeld, Brown, Heier 2006; 355 Bakri, McCannel, Edwards 2008; 246 Hoang, Mendonca, Della Torre 2012; 119 Choi, Ortube, McCannel 2011; 31 Singerman, Masonson, Patel 2008; 92 Sniegowski, Mandava, Kahook 2010; 4 Gonzales 2005; 25 Tseng, Vance, Della Torre 2012; 21 |
| References_xml | – volume: 92 start-page: 1606 year: 2008 article-title: Pegaptanib sodium for neovascular age-related macular degeneration: third-year safety results of the VEGF Inhibition Study in Ocular Neovascularisation (VISION) trial publication-title: Br J Ophthalmol – volume: 31 start-page: 1028 year: 2011 article-title: Sustained elevated intraocular pressures after intravitreal injection of bevacizumab, ranibizumab, and pegaptanib publication-title: Retina – volume: 21 start-page: 241 year: 2012 article-title: Sustained increased intraocular pressure related to intravitreal antivascular endothelial growth factor therapy for neovascular age-related macular degeneration publication-title: J Glaucoma – volume: 43 start-page: 328 year: 2012 article-title: Glaucoma filtration surgery following sustained elevation of intraocular pressure secondary to intravitreal anti-VEGF injections publication-title: Ophthalmic Surg Lasers Imaging – volume: 355 start-page: 1419 year: 2006 article-title: Ranibizumab for neovascular age-related macular degeneration publication-title: N Engl J Med – volume: 355 start-page: 1432 year: 2006 article-title: Ranibizumab versus verteporfin for neovascular age-related macular degeneration publication-title: N Engl J Med – volume: 32 start-page: 1295 year: 2012 article-title: A lack of delayed intraocular pressure elevation in patients treated with intravitreal injection of bevacizumab and ranibizumab publication-title: Retina – volume: 113 start-page: 992 year: 2006 article-title: Pegaptanib sodium for neovascular age-related macular degeneration: two-year safety results of the two prospective, multicenter, controlled clinical trials publication-title: Ophthalmology – volume: 19 start-page: 437 year: 2010 article-title: In vitro effects of antivascular endothelial growth factors on cultured human trabecular meshwork cells publication-title: J Glaucoma – volume: 25 start-page: 815 year: 2005 article-title: Enhanced efficacy associated with early treatment of neovascular age-related macular degeneration with pegaptanib sodium: an exploratory analysis publication-title: Retina – volume: 25 start-page: 123 year: 1980 article-title: The distribution of intraocular pressures in the general population publication-title: Surv Ophthalmol – volume: 246 start-page: 955 year: 2008 article-title: Persisent ocular hypertension following intravitreal ranibizumab publication-title: Graefes Arch Clin Exp Ophthalmol – volume: 4 start-page: 28 year: 2010 article-title: Sustained intraocular pressure elevation after intravitreal injection of bevacizumab and ranibizumab associated with trabeculitis publication-title: Open Ophthalmol J – volume: 119 start-page: 321 year: 2012 article-title: Effect on intraocular pressure in patients receiving unilateral intravitreal anti-vascular endothelial growth factor injections publication-title: Ophthalmology – volume: 95 start-page: 1111 year: 2011 article-title: Sustained elevation of intraocular pressure after intravitreal injections of anti-VEGF agents publication-title: Br J Ophthalmol – volume: 94 start-page: 1611 year: 2010 article-title: Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study publication-title: Br J Ophthalmol |
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| Snippet | Objective To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. Methods A posthoc analysis was conducted on all IOP... To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation. A posthoc analysis was conducted on all IOP measurements, except... To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation.OBJECTIVETo assess the rate of pegaptanib-associated sustained... |
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| SubjectTerms | Adult Angiogenesis Inhibitors - therapeutic use Aptamers, Nucleotide - therapeutic use Clinical trials Double-Blind Method Female Glaucoma Humans Hypertension Inflammation Intraocular Pressure - drug effects Intravitreal Injections Macular degeneration Male Middle Aged Molecular weight Studies Tonometry, Ocular Vascular endothelial growth factor Vascular Endothelial Growth Factor A - antagonists & inhibitors Wet Macular Degeneration - drug therapy |
| Title | Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study |
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