Session Title: New Drug Treatment
Session Date/Time: Saturday 13/09/2014 | 14:30-16:30
Paper Time: 14:46
Venue: Boulevard F
First Author: : T.Wong SINGAPORE
Co Author(s): :
To evaluate whether 2 key prognostic factors, patient age and baseline axial length, influence visual outcomes in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV) receiving intravitreal aflibercept (IVT-AFL).
A double-masked, sham-controlled, Phase 3 multicentre study (MYRROR) conducted in 5 Asian countries or regions (Hong Kong, Japan, Republic of Korea, Singapore, and Taiwan) between November 2010 and August 2013.
Patients with myopic CNV were randomised 3:1 to receive either IVT-AFL 2.0 mg or sham treatment (stratified by country) over 48 weeks. Patients assigned IVT-AFL received a single active injection at baseline followed by additional injections (IVT-AFL or sham), after the assessment of predefined retreatment criteria, every 4 weeks through Week 44. In the control group, patients were given 1 sham injection at baseline followed by repeated sham injections every 4 weeks through Week 20. At Week 24, after assessment of the primary efficacy endpoint (mean change in best-corrected visual acuity [BCVA] from baseline), patients in the control group received a single active IVT-AFL injection; additional injections (IVT-AFL or sham) were administered, only if the assessment of the predefined retreatment criteria was positive, every 4 weeks through Week 44. We report on initial exploratory post hoc analyses performed to evaluate the impact of baseline patient age and axial length on mean change in BCVA at Weeks 24 (W24) and 48 (W48). Patient subgroups for both variables were based on median cut-offs (age: ≤62 years vs >62; axial length: ≤28.6mm vs >28.6mm). Pearson correlation analyses were also performed. All data presented are last observation carried forward.
121 patients were randomised, 90 to IVT-AFL and 31 to sham. In the total population, mean BCVA changes were 12.0/13.5 letters (W24/W48) for IVT-AFL vs -2.0/3.9 for sham+IVT-AFL (P<0.0001 each). With age ≤62 years, mean BCVA changes were 13.0/14.7 letters (W24/W48) for IVT-AFL (n=46) vs -0.8/ 8.1 for sham+IVT-AFL (n=17). With age >62 years, changes were 11.1/12.2 letters (W24/W48) for IVT-AFL (n=44) vs -3.6/-1.2 for sham+IVT-AFL (n=14). With axial length ≤28.6 mm, mean BCVA changes were 12.6/13.8 letters (W24/W48) for IVT-AFL (n=43) vs -2.1/1.7 for sham/sham+IVT-AFL (n=18). With axial length >28.6 mm, changes were 11.6/13.2 letters (W24/W48) for IVT-AFL (n=47) vs -2.0/7.0 for sham+IVT-AFL (n=13). Correlation coefficients for BCVA change based on baseline age were -0.234 and -0.215 (W24/W48) (both P<0.05); coefficients based on baseline axial length were nonsignificant. In the first study quarter the median injection number in the IVT-AFL arm was 2; for each remaining study quarter (2-4) the median injection number was 0. In ‘sham + IVT-AFL’ in study quarters 3 and 4 the median injection number was 2 and 1, respectively. Overall incidence of ocular treatment-emergent adverse events in the treatment groups was similar; most events were mild, and no deaths were reported.
IVT-AFL was well tolerated and associated with clinically and statistically meaningful improvements in visual acuity, both in the overall study population and in subgroups of patients based on age or axial length. Treatment benefits may be greater among younger patients with myopic CNV, but there was no clear trend that baseline axial length influences treatment outcomes. The findings further support the benefits of treatment with IVT-AFL in eyes with myopic CNV early in the course of treatment and with a limited number of injections irrespective of severity of myopia.