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      Month 12 Outcomes After Treatment Change at Month 6 Among Poor Responders to Aflibercept or Bevacizumab in Eyes with Macular Edema Secondary to Central or Hemiretinal Vein Occlusion : A Secondary Analysis of the SCORE2 Study

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          Abstract

          <div class="section"> <a class="named-anchor" id="ab-ebr180025-1"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e599">Question</h5> <p id="d663881e601">In eyes with macular edema secondary to central retinal or hemiretinal vein occlusion, is switching treatment after a poor response to bevacizumab or aflibercept associated with improvement in visual acuity or central subfield thickness? </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-2"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e604">Findings</h5> <p id="d663881e606">In this secondary analysis of a nonrandomized trial in which 49 patients with central retinal or hemiretinal vein occlusion responded poorly to treatment with bevacizumab or aflibercept, eyes with treatment switched from bevacizumab to aflibercept at month 6 showed improvement in visual acuity and central subfield thickness at month 12. Few eyes had a poor response to aflibercept, and therefore, treatment was switched to dexamethasone in few. </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-3"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e609">Meaning</h5> <p id="d663881e611">Eyes with central retinal or hemiretinal vein occlusion that have a poor response to bevacizumab may benefit after switching to aflibercept treatment; however, the small sample size and lack of controls in this study preclude definitive conclusions. </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-4"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e615">Importance</h5> <p id="d663881e617">Information is needed to assess switching treatment in eyes with a poor response to 6 months of monthly administration of aflibercept or bevacizumab for macular edema from central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-5"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e620">Objective</h5> <p id="d663881e622">To investigate visual acuity letter score (VALS) and central subfield thickness (CST) changes from month 6 to 12 among eyes with a poor response at month 6 to monthly dosing of aflibercept or bevacizumab in the Study of Comparative Treatments for Retinal Vein Occlusion 2. </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-6"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e625">Design, Setting, and Participants</h5> <p id="d663881e627">This secondary analysis of the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) was conducted at 66 private practice or academic centers in the United States. Participants included 49 patients (1 eye from each patient evaluated) with CRVO- or HRVO-associated macular edema and a protocol-defined poor response to aflibercept or bevacizumab treatment at month 6. The first month 6 visit occurred on September 8, 2015, and the last month 12 visit occurred on October 24, 2016. </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-7"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e630">Interventions</h5> <p id="d663881e632">Treatment in eyes receiving monthly aflibercept was switched to a dexamethasone implant at month 6 and, if needed, at months 9, 10, or 11. Treatment in eyes receiving monthly bevacizumab was switched to aflibercept at months 6, 7, and 8, and then to a treat-and-extend aflibercept regimen until month 12. </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-8"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e635">Main Outcomes and Measures</h5> <p id="d663881e637">Change from month 6 to 12 in VALS and CST.</p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-9"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e640">Results</h5> <p id="d663881e642">Of the 49 participants at month 6, aflibercept treatment had failed in 14 (6 [43%] women; mean [SD] age, 70.4 [13.0] years). Bevacizumab treatment had failed in 35 patients (16 [46%] women; mean age, 70.0 [13.2] years). In 14 eyes with treatment switched from aflibercept to dexamethasone, the estimated mean change from month 6 to 12 in VALS was 2.63 (95% CI, −3.29 to 8.56; <i>P</i> = .37) and 46.0 μm (95% CI, −80.9 to 172.9 μm; <i>P</i> = .46) for CST. In 35 eyes with treatment switched from bevacizumab to aflibercept, the estimated mean change from month 6 to 12 in VALS was 10.27 (95% CI, 6.05-14.49; <i>P</i> &lt; .001) and −125.4 μm (95% CI, −180.9 to −69.9 μm; <i>P</i> &lt; .001) for CST. </p> </div><div class="section"> <a class="named-anchor" id="ab-ebr180025-10"> <!-- named anchor --> </a> <h5 class="section-title" id="d663881e657">Conclusions and Relevance</h5> <p id="d663881e659">Eyes treated with aflibercept after a poor response to bevacizumab had improvement in VALS and CST. Few eyes had a poor response to aflibercept, and therefore, few eyes were switched to dexamethasone. Caution is warranted in interpreting these results owing to the small number of eyes and lack of comparison groups. These factors preclude definitive assessment of whether the switching strategy is superior to maintaining treatment. </p> </div><p class="first" id="d663881e662">This secondary analysis of the SCORE2 study examines the results of treatment switching in patients with central or hemiretinal vein occlusion who responded poorly to 6 months of aflibercept or bevacizumab therapy. </p>

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          Most cited references 8

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          Effect of Bevacizumab vs Aflibercept on Visual Acuity Among Patients With Macular Edema Due to Central Retinal Vein Occlusion: The SCORE2 Randomized Clinical Trial.

           Ingrid Scott,  Paul VanVeldhuisen (corresponding) ,  Michael Ip (2017)
          Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data.
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            Intravitreal aflibercept for macular oedema secondary to central retinal vein occlusion in patients with prior treatment with bevacizumab or ranibizumab.

            PurposeTo report the visual and anatomic outcomes in eyes with macular oedema (MO) secondary to central retinal vein occlusion (CRVO) that were switched from either intravitreal bevacizumab or ranibizumab to intravitreal aflibercept.MethodsTwo-center retrospective chart review. Eyes with MO secondary to CRVO that received a minimum of three intravitreal injections of bevacizumab or ranibizumab and were switched to intravitreal aflibercept for persistent or recurrent MO not responding to either bevacizumab and/or ranibizumab.ResultsIn all 42 eyes of 42 patients were included in the study. The median visual acuity before the switch was 20/126, 1 month after the first injection of aflibercept 20/89 (P=0.0191), and at the end of the follow-up 20/100 (P=0.2724). The median CRT before the switch was 536 μm, 1 month after the first injection of aflibercept 293.5 μm (P=0.0038), and at the end of the follow-up 279 μm (P=0.0013 compared to before the switch). The median number of weeks between injections before the switch was 5.6 and after the switch was 7.6 (P<0.0001).ConclusionConverting eyes with refractory MO due to CRVO to aflibercept can result in stabilization of the vision, improved macular anatomy, and extension of the injection interval.
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              Response to aflibercept as secondary therapy in patients with persistent retinal edema due to central retinal vein occlusion initially treated with bevacizumab or ranibizumab.

              Recent advances have given practitioners options for the treatment of macular edema secondary to central retinal vein occlusion. These options include steroid injections and implants as well as anti-vascular endothelial growth factor medications. However, there is little in the medical literature to guide secondary therapy when an initial treatment strategy is insufficient. The authors present encouraging results from the treatment of six consecutive cases of central retinal vein occlusion treated with aflibercept as a secondary therapy for macular edema refractory to repeated intravitreal bevacizumab or ranibizumab injections.
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                Author and article information

                Journal
                JAMA Ophthalmology
                JAMA Ophthalmol
                American Medical Association (AMA)
                2168-6165
                December 27 2018
                Affiliations
                [1 ]Doheny Eye Institute, University of California, Los Angeles
                [2 ]The Emmes Corporation, Rockville, Maryland
                [3 ]Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania
                [4 ]University of Wisconsin Fundus Photograph Reading Center, Madison
                [5 ]National Ophthalmic Research Institute, Fort Myers, Florida
                [6 ]Paducah Retinal Center, Paducah, Kentucky
                Article
                10.1001/jamaophthalmol.2018.6111
                6439712
                30589922
                © 2018

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