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Michael S Ip, Paul C VanVeldhuisen, Ingrid U Scott, Barbara A Blodi, Tom Ghuman, Carl W Baker, Neal L. Oden; SCORE2 Month 6 to Month 12 Results: 12 Month Outcomes of Treatment Change among Poor Responders at Month 6. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5971.
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© ARVO (1962-2015); The Authors (2016-present)
The Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) demonstrated that, among patients with macular edema due to central retinal vein occlusion or hemi-retinal vein occlusion, monthly intravitreal bevacizumab was non-inferior to monthly intravitreal aflibercept with respect to visual acuity after 6 months of treatment. This analysis explores whether a treatment change at month 6 in those eyes that meet the protocol-defined criteria for a poor response may result in improvement in visual acuity and/or central subfield thickness (CST) at month 12.
In SCORE2, participants originally assigned to monthly aflibercept (2.0mg) with a protocol-defined poor response were assigned to an intravitreal injection of a dexamethasone implant (700 ug) at month 6 followed by a PRN injection of the implant at month 9, 10 or 11 (n=15 eyes, 14 of which received dexamethasone). Participants originally assigned to monthly bevacizumab (1.25mg) with a protocol-defined poor response were assigned to intravitreal aflibercept at months 6, 7 and 8, and then on a treat-and-extend regimen up until month 12 (n=39 eyes).
The mean change from month 6 to 12 in VALS was 2.5 (P=0.36) in eyes switched at month 6 from aflibercept monthly treatment to the dexamethasone implant and the mean change from month 6 to 12 in CST was 39 um (P=0.49). Mean change from month 6 to 12 in VALS was 9.0 (P=<0.01) in the eyes switched at month 6 from bevacizumab monthly treatment to aflibercept, and the mean change from month 6 to 12 in CST was -110 um (P=<0.01). The mean number of dexamethasone implants between months 6-11 was 1.8 in the group switched to the dexamethasone implant, and the mean number of injections between months 6-11 was 5.0 in the group switched to aflibercept.
Few eyes in either the aflibercept or bevacizumab groups met the protocol-defined criteria for a poor response at month 6. However, eyes that had a poor response to a bevacizumab monthly regimen over 6 months showed both an improvement in VALS and CST at month 12 after receiving aflibercept treatment.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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