Session Title: Free Paper Session 16: Vascular Diseases & Diabetic Retinopathy IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 16:42
Venue: Room 114
First Author: : K.Ohno Matsui JAPAN
Co Author(s): : G. Cheung T. Wong T. Li S. Leal
Choroidal neovascularisation (CNV) is a common vision-threatening complication of pathologic myopia (myopic CNV). In approximately 40% of eyes with high myopia, progression to myopic macular degeneration (MMD) can be observed. Untreated myopic CNV has a dismal prognosis, and after 5 years approximately 90% of eyes have a best-corrected visual acuity (BCVA) lower than 20/200. The aim of the current post-hoc analysis was to determine the influence of MMD severity on treatment outcomes with intravitreal aflibercept (IVT-AFL) in myopic CNV.
The MYRROR study was a randomised, double-masked study that evaluated the use of IVT-AFL compared with sham/IVT-AFL over 48 weeks.
The MYRROR study included 122 patients aged ≥18 years with high myopia (worse than or equal to –6.0 dioptres or axial length of ≥26.5 mm), active myopic CNV, and BCVA of 73–35 Early Treatment Diabetic Retinopathy Study letters in the study eye. Eligible patients were randomised in a 3:1 ratio to receive IVT-AFL or sham/IVT-AFL and stratiﬁed by country; sham patients were allowed to receive IVT-AFL beginning at Week 24. All patients in the MYRROR study who had a baseline colour fundus photograph that was evaluable for an MMD grading according to the META-analysis for Pathologic Myopia (META-PM) definitions were included in the current post-hoc analysis. Baseline and Week 48 colour fundus and fluorescein angiography images were retrospectively graded for MMD using the META-PM grading scheme: Category 1 (tessellated fundus); Category 2 (diffuse chorioretinal atrophy); Category 3 (patchy chorioretinal atrophy); Category 4 (macular atrophy). Visual and anatomical outcomes were evaluated for eyes stratified by MMD severity.
115 eyes were included in this post-hoc analysis (IVT-AFL [n=87]; sham/IVT-AFL [n=28]). Baseline MMD severity was distributed across patients as follows: Category 1: 17%; 2: 58%; 3: 19%, 4: 6%. When all baseline MMD categories were considered, higher MMD category was associated with older age (P=0.007) and longer axial length (P=0.025). When pooling categories (Grade ≤2 [n=86] and Grade >2 [n=29]), higher baseline MMD was associated with lower baseline central retinal thickness (CRT) (P=0.033). IVT-AFL-treated eyes with mild or severe MMD showed clinically meaningful visual improvements at Week 48 (+13.5 vs +12.4 letters). Eyes gaining ≥15 letters showed a slight numerical trend for better outcomes with mild baseline MMD (53.0% vs 38.1%; P=0.233). There was a numerical trend toward a lesser degree of reduction in CRT from baseline to Week 48 (–98.2 µm versus –46.3 µm), reflecting lower baseline CRT values with higher MMD. The majority of IVT-AFL-treated eyes had no change in MMD category (75.6%). In eyes with increase in MMD category, mean BCVA change at Week 48 was +8.3 letters; 47.4% of those eyes gained ≥10 letters. Seven (5.7%) patients had a serious adverse event (AE) (all IVT-AFL); 1 patient had a serious ocular AE (macular hole).
Visual acuity gains and morphological outcomes were not affected by baseline MMD severity in patients treated with IVT-AFL. Eyes with an increase in the MMD category also showed meaningful BCVA gains through to the end of the study at Week 48. Based on the findings of this retrospective analysis, there appears to be a clear benefit of IVT-AFL treatment in eyes with myopic CNV, regardless of baseline MMD stage or increase in MMD progression category.