Chui Ming Gemmy Cheung1,2,3, Kyoko Ohno-Matsui4, Tien Yin Wong1,2,3, Tummy Li5, Friedrich Asmus6,7, Sérgio Leal8. 1. Singapore National Eye Centre, Singapore, Singapore. 2. Singapore Eye Research Institute, Singapore, Singapore. 3. Duke-NUS Graduate Medical School, National University of Singapore, Singapore, Singapore. 4. Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan. 5. Bayer Pharmaceuticals, Beijing, China. 6. Bayer AG, Berlin, Germany. 7. Department of Neurodegeneration, Center of Neurology, University Hospital of Tübingen, and Hertie Institute for Clinical Brain Research, Tübingen, Germany. 8. Bayer AG, Basel, Switzerland.
Abstract
PURPOSE: To determine the influence of baseline myopic macular degeneration (MMD) severity on outcomes with intravitreal aflibercept (IVT-AFL) in patients with myopic choroidal neovascularization (CNV). METHODS: MYRROR was a randomized, double-masked study in patients with myopic CNV treated withIVT-AFL/sham over 48 weeks. At baseline/week 48, images were retrospectively graded for MMD. RESULTS: At baseline, 115 eyes had a valid MMD grading result; at week 48, grading results were available for 99 eyes [IVT-AFL (n = 78)/sham (n = 21)]. Severity of baseline MMD was distributed as follows: category 1: 19/115 (17%); category 2: 67/115 (58%); category 3: 22/115 (19%); category 4: 7/115 (6%). Higher MMD category was associated with older age (nominal p = 0.007) and longer axial length (nominal p = 0.025). At week 48, patients in the mild and severe groups had visual acuity gains of +13.5 and +12.4 letters, respectively. Baseline MMD severity did not significantly affect visual/anatomical outcomes or number of treatments. Visual Functioning Questionnaire-25 scores improved more in mild (+5.6) versus severe (+0.4) MMD (nominal p = 0.03). There were no new safety events. CONCLUSIONS:Visual acuity gains, morphological outcomes and dosing frequency were not affected by baseline MMD severity in patients treated with IVT-AFL. A benefit with IVT-AFL treatment was observed for all baseline MMD stages included in this study.
RCT Entities:
PURPOSE: To determine the influence of baseline myopic macular degeneration (MMD) severity on outcomes with intravitreal aflibercept (IVT-AFL) in patients with myopic choroidal neovascularization (CNV). METHODS: MYRROR was a randomized, double-masked study in patients with myopic CNV treated with IVT-AFL/sham over 48 weeks. At baseline/week 48, images were retrospectively graded for MMD. RESULTS: At baseline, 115 eyes had a valid MMD grading result; at week 48, grading results were available for 99 eyes [IVT-AFL (n = 78)/sham (n = 21)]. Severity of baseline MMD was distributed as follows: category 1: 19/115 (17%); category 2: 67/115 (58%); category 3: 22/115 (19%); category 4: 7/115 (6%). Higher MMD category was associated with older age (nominal p = 0.007) and longer axial length (nominal p = 0.025). At week 48, patients in the mild and severe groups had visual acuity gains of +13.5 and +12.4 letters, respectively. Baseline MMD severity did not significantly affect visual/anatomical outcomes or number of treatments. Visual Functioning Questionnaire-25 scores improved more in mild (+5.6) versus severe (+0.4) MMD (nominal p = 0.03). There were no new safety events. CONCLUSIONS: Visual acuity gains, morphological outcomes and dosing frequency were not affected by baseline MMD severity in patients treated with IVT-AFL. A benefit with IVT-AFL treatment was observed for all baseline MMD stages included in this study.