Influence of myopic macular degeneration severity on treatment outcomes with intravitreal aflibercept in the MYRROR study.

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.

Intravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization: The MYRROR Study.

PURPOSE: To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). DESIGN: An international, phase III, multicenter, randomized, double-masked, sham-controlled study. PARTICIPANTS: Patients aged ≥ 18 years with high myopia (≤-6.0 diopters or axial length of ≥ 26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73-35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. METHODS: Patients were randomized 3:1 to intravitreal aflibercept or sham. In the intravitreal aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. MAIN OUTCOME MEASURES: Mean change in BCVA from baseline to week 24. RESULTS: A total of 122 patients were randomized to intravitreal aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal aflibercept and sham groups gained 12.1 and lost 2 letters, respectively (P < 0.0001). By week 48, patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained 13.5 and 3.9 letters. Patients in the intravitreal aflibercept group received 2 injections (median) in the first study quarter (week 0-8). Median number of injections in quarters 2 to 4 was 0. Patients in the "sham/intravitreal aflibercept" group received 2 and 1 (median) intravitreal aflibercept injections in quarters 3 and 4. Central retinal thickness improved in parallel with visual gains. Incidence of ocular adverse events was similar in both groups through week 48 (37.4% vs. 38.7); most were assessed by investigators as mild. No deaths occurred. CONCLUSIONS: Intravitreal aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal aflibercept should be considered as a treatment option for myopic CNV.