Month 60 Outcomes After Treatment Initiation With Anti–Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion
To investigate 5-year outcomes in eyes initially treated with aflibercept or bevacizumab for macular edema due to central retinal or hemiretinal vein occlusion. Long-term follow-up (LTF) after a randomized clinical trial from 64 centers in the United States. Participants were followed up to 60 month...
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| Published in: | American journal of ophthalmology Vol. 240; pp. 330 - 341 |
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| Main Authors: | , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
Elsevier Inc
01.08.2022
Elsevier Limited |
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| ISSN: | 0002-9394, 1879-1891, 1879-1891 |
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| Abstract | To investigate 5-year outcomes in eyes initially treated with aflibercept or bevacizumab for macular edema due to central retinal or hemiretinal vein occlusion.
Long-term follow-up (LTF) after a randomized clinical trial from 64 centers in the United States. Participants were followed up to 60 months and treated at investigator discretion after completing the 12-month treatment protocol. Main outcomes were visual acuity letter score (VALS) and central subfield thickness (CST) on optical coherence tomography.
Seventy-five percent (248/330) of eligible participants completed at least 1 visit between months 24 and 60, and 45% completed the month 60 visit. Among participants completing month 60, overall mean VALS improvement over baseline was 13.5 (95% CI: 9.6, 17.5), less than the mean improvement of 20.6 (95% CI: 18.7, 22.4) observed at month 12, with no significant differences between originally assigned study groups. Further, 66% (99/150) had at least 1 treatment between months 48 and 60 with a mean (SD) of 3.41 (3.69) treatments over this period. Mean CST was 671 μm at baseline and 261 μm (95% CI: 241.2, 280.9) at month 60.
Although VALS improved substantially when patients were treated per protocol through month 12, improvement lessened when treatment was at investigator discretion and fewer treatments were received although VALS remained markedly improved over baseline through year 5. Most patients continued to receive treatment in year 5. This suggests that continued monitoring and, if warranted, treatment with anti-VEGF therapy benefits patients with macular edema associated with central retinal or hemiretinal vein occlusion. Publication of this article is sponsored by the American Ophthalmological Society. |
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| AbstractList | PURPOSETo investigate 5-year outcomes in eyes initially treated with aflibercept or bevacizumab for macular edema due to central retinal or hemiretinal vein occlusion.METHODSLong-term follow-up (LTF) after a randomized clinical trial from 64 centers in the United States. Participants were followed up to 60 months and treated at investigator discretion after completing the 12-month treatment protocol. Main outcomes were visual acuity letter score (VALS) and central subfield thickness (CST) on optical coherence tomography.RESULTSSeventy-five percent (248/330) of eligible participants completed at least 1 visit between months 24 and 60, and 45% completed the month 60 visit. Among participants completing month 60, overall mean VALS improvement over baseline was 13.5 (95% CI: 9.6, 17.5), less than the mean improvement of 20.6 (95% CI: 18.7, 22.4) observed at month 12, with no significant differences between originally assigned study groups. Further, 66% (99/150) had at least 1 treatment between months 48 and 60 with a mean (SD) of 3.41 (3.69) treatments over this period. Mean CST was 671 μm at baseline and 261 μm (95% CI: 241.2, 280.9) at month 60.CONCLUSIONSAlthough VALS improved substantially when patients were treated per protocol through month 12, improvement lessened when treatment was at investigator discretion and fewer treatments were received although VALS remained markedly improved over baseline through year 5. Most patients continued to receive treatment in year 5. This suggests that continued monitoring and, if warranted, treatment with anti-VEGF therapy benefits patients with macular edema associated with central retinal or hemiretinal vein occlusion. Publication of this article is sponsored by the American Ophthalmological Society. To investigate 5-year outcomes in eyes initially treated with aflibercept or bevacizumab for macular edema due to central retinal or hemiretinal vein occlusion. Long-term follow-up (LTF) after a randomized clinical trial from 64 centers in the United States. Participants were followed up to 60 months and treated at investigator discretion after completing the 12-month treatment protocol. Main outcomes were visual acuity letter score (VALS) and central subfield thickness (CST) on optical coherence tomography. Seventy-five percent (248/330) of eligible participants completed at least 1 visit between months 24 and 60, and 45% completed the month 60 visit. Among participants completing month 60, overall mean VALS improvement over baseline was 13.5 (95% CI: 9.6, 17.5), less than the mean improvement of 20.6 (95% CI: 18.7, 22.4) observed at month 12, with no significant differences between originally assigned study groups. Further, 66% (99/150) had at least 1 treatment between months 48 and 60 with a mean (SD) of 3.41 (3.69) treatments over this period. Mean CST was 671 μm at baseline and 261 μm (95% CI: 241.2, 280.9) at month 60. Although VALS improved substantially when patients were treated per protocol through month 12, improvement lessened when treatment was at investigator discretion and fewer treatments were received although VALS remained markedly improved over baseline through year 5. Most patients continued to receive treatment in year 5. This suggests that continued monitoring and, if warranted, treatment with anti-VEGF therapy benefits patients with macular edema associated with central retinal or hemiretinal vein occlusion. Publication of this article is sponsored by the American Ophthalmological Society. To investigate 5-year outcomes in eyes initially treated with aflibercept or bevacizumab for macular edema due to central retinal or hemiretinal vein occlusion.PURPOSETo investigate 5-year outcomes in eyes initially treated with aflibercept or bevacizumab for macular edema due to central retinal or hemiretinal vein occlusion.Long-term follow-up (LTF) after a randomized clinical trial from 64 centers in the United States. Participants were followed up to 60 months and treated at investigator discretion after completing the 12-month treatment protocol. Main outcomes were visual acuity letter score (VALS) and central subfield thickness (CST) on optical coherence tomography.METHODSLong-term follow-up (LTF) after a randomized clinical trial from 64 centers in the United States. Participants were followed up to 60 months and treated at investigator discretion after completing the 12-month treatment protocol. Main outcomes were visual acuity letter score (VALS) and central subfield thickness (CST) on optical coherence tomography.Seventy-five percent (248/330) of eligible participants completed at least 1 visit between months 24 and 60, and 45% completed the month 60 visit. Among participants completing month 60, overall mean VALS improvement over baseline was 13.5 (95% CI: 9.6, 17.5), less than the mean improvement of 20.6 (95% CI: 18.7, 22.4) observed at month 12, with no significant differences between originally assigned study groups. Further, 66% (99/150) had at least 1 treatment between months 48 and 60 with a mean (SD) of 3.41 (3.69) treatments over this period. Mean CST was 671 μm at baseline and 261 μm (95% CI: 241.2, 280.9) at month 60.RESULTSSeventy-five percent (248/330) of eligible participants completed at least 1 visit between months 24 and 60, and 45% completed the month 60 visit. Among participants completing month 60, overall mean VALS improvement over baseline was 13.5 (95% CI: 9.6, 17.5), less than the mean improvement of 20.6 (95% CI: 18.7, 22.4) observed at month 12, with no significant differences between originally assigned study groups. Further, 66% (99/150) had at least 1 treatment between months 48 and 60 with a mean (SD) of 3.41 (3.69) treatments over this period. Mean CST was 671 μm at baseline and 261 μm (95% CI: 241.2, 280.9) at month 60.Although VALS improved substantially when patients were treated per protocol through month 12, improvement lessened when treatment was at investigator discretion and fewer treatments were received although VALS remained markedly improved over baseline through year 5. Most patients continued to receive treatment in year 5. This suggests that continued monitoring and, if warranted, treatment with anti-VEGF therapy benefits patients with macular edema associated with central retinal or hemiretinal vein occlusion. Publication of this article is sponsored by the American Ophthalmological Society.CONCLUSIONSAlthough VALS improved substantially when patients were treated per protocol through month 12, improvement lessened when treatment was at investigator discretion and fewer treatments were received although VALS remained markedly improved over baseline through year 5. Most patients continued to receive treatment in year 5. This suggests that continued monitoring and, if warranted, treatment with anti-VEGF therapy benefits patients with macular edema associated with central retinal or hemiretinal vein occlusion. Publication of this article is sponsored by the American Ophthalmological Society. |
| Author | Oden, Neal L. Ip, Michael S. Scott, Ingrid U. Blodi, Barbara A. VanVeldhuisen, Paul C. |
| Author_xml | – sequence: 1 givenname: Ingrid U. surname: Scott fullname: Scott, Ingrid U. email: iscott@pennstatehealth.psu.edu organization: From the Departments of Ophthalmology and Public Health Sciences (I.U.C.), Penn State College of Medicine, Hershey, Pennsylvania – sequence: 2 givenname: Paul C. surname: VanVeldhuisen fullname: VanVeldhuisen, Paul C. organization: The Emmes Company, LLC (P.C.V., N.L.O.), Rockville, Maryland – sequence: 3 givenname: Neal L. surname: Oden fullname: Oden, Neal L. organization: The Emmes Company, LLC (P.C.V., N.L.O.), Rockville, Maryland – sequence: 4 givenname: Michael S. surname: Ip fullname: Ip, Michael S. organization: Doheny Eye Institute (M.S.I.), University of California, Los Angeles, California – sequence: 5 givenname: Barbara A. surname: Blodi fullname: Blodi, Barbara A. organization: University of Wisconsin Fundus Photograph Reading Center (B.A.B.), Madison, Wisconsin, USA |
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| Cites_doi | 10.1016/j.ophtha.2011.12.005 10.1016/j.ajo.2014.07.027 10.1016/j.ophtha.2009.07.017 10.1016/j.ophtha.2010.03.032 10.1016/j.ophtha.2014.01.027 10.1016/0002-9394(84)90316-7 10.1016/j.ophtha.2008.10.017 10.1016/j.ophtha.2014.08.031 10.1016/j.ophtha.2015.09.035 10.1016/j.ophtha.2010.02.022 10.1016/j.ajo.2012.09.026 10.1001/jama.2013.281053 10.1016/S0161-6420(95)30849-4 10.1016/j.ophtha.2010.02.021 10.1016/S0161-6420(95)30848-2 10.1001/archopht.1996.01100140443012 10.1136/bjophthalmol-2012-301504 10.1001/archophthalmol.2009.233 10.1001/jamaophthalmol.2017.6843 10.1016/j.ophtha.2012.01.042 10.1001/archophthalmol.2009.234 10.1016/j.ophtha.2011.02.038 10.1016/j.ophtha.2013.08.038 10.1016/j.ophtha.2011.05.014 10.1001/archopht.1993.01090080083022 10.1186/s12874-018-0653-0 10.1001/jama.2017.4568 10.1001/jamaophthalmol.2019.3947 |
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| SubjectTerms | Angiogenesis Inhibitors Bevacizumab - therapeutic use Diabetes Diabetic retinopathy Edema FDA approval Humans Intravitreal Injections Lasers Macular Edema - diagnosis Macular Edema - drug therapy Macular Edema - etiology Medical records Monoclonal antibodies Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors Recombinant Fusion Proteins Retinal Vein Occlusion - complications Retinal Vein Occlusion - diagnosis Retinal Vein Occlusion - drug therapy Tomography, Optical Coherence Vascular endothelial growth factor Vascular Endothelial Growth Factor A - antagonists & inhibitors |
| Title | Month 60 Outcomes After Treatment Initiation With Anti–Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion |
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