Session Title: New Drug Treatment
Session Date/Time: Saturday 13/09/2014 | 14:30-16:30
Paper Time: 14:30
Venue: Boulevard F
First Author: : J-FKorobelnik FRANCE
Co Author(s): :
To further evaluate visual acuity outcomes in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV) receiving intravitreal aflibercept (IVT-AFL) injection or sham treatment.
Data are from the MYRROR study. This was an international, Phase 3, multicentre, randomised, double-masked, sham-controlled study conducted in 20 sites across 5 countries or regions in Asia (Hong Kong, Japan, Republic of Korea, Singapore, and Taiwan).
Patients with myopic CNV were randomised 3:1 to the IVT AFL or sham + IVT-AFL treatment arm over 48 weeks. Patients in the IVT-AFL arm received a single IVT-AFL 2-mg injection at baseline followed by additional injections in case of persistence/recurrence of CNV (established on assessments every 4 weeks until Week 44). Patients in the sham + IVT-AFL arm received sham injections at each visit from baseline through Week 20; at Week 24, these patients received a single IVT-AFL 2-mg injection, followed by additional injections (IVT-AFL or sham) according to assessment of the same predefined retreatment criteria every 4 weeks through Week 44. We report on exploratory post hoc analyses designed to evaluate the proportion of patients achieving a ≥10-letter or ≥15-letter gain (ETDRS letters) over the 48-week study period and the associated time course of these visual acuity gains. Data presented are from the full analysis set (FAS) using the last observation carried forward method.
121 patients were included (FAS); 90 patients received IVT-AFL and 31 received sham+IVT-AFL. At Week 24 in the IVT-AFL arm, 63.3% (n=57) and 38.9% (n=35) of patients had gained ≥10 or ≥15 letters from baseline, respectively. In the sham+IVT-AFL arm, with sham treatment only through Week 24, 12.9% (n=4) and 9.7% (n=3) had gained ≥10 or ≥15 letters from baseline, respectively. By Week 48, the proportion of patients gaining ≥10 or ≥15 letters from baseline in the IVT-AFL arm was 68.9% and 50.0%, respectively. At Week 48 in the sham+IVT-AFL arm (i.e., 24 weeks after IVT-AFL initiation), 41.9% and 29.0% of patients had gained ≥10 or ≥15 letters from baseline, respectively. Results of Kaplan-Meier analyses on the time course of letters gained will be available for EURETINA 2014. 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 the sham+IVT-AFL arm, in study quarters 3 and 4, the median injection number was 2 and 1, respectively. The incidence of ocular treatment-emergent adverse events was comparable across the 2 treatment groups. The majority of events were mild, and no deaths were reported.
In this study, the proportion of patients treated with IVT-AFL who achieved at least a 10-letter or at least a 15-letter gain at Week 24 was well maintained and even slightly increased at Week 48. Clinically meaningful benefits from treatment with IVT-AFL could also be observed at Week 48 in the sham+IVT-AFL arm in which active treatment was delayed by study design until Week 24. In both treatment groups, visual benefits could be observed with only a limited number of IVT-AFL injections early after initiation of treatment. However, the proportion of 10- and 15-letter gainers in the sham+IVT-AFL group did not reach the extent observed in the IVT-AFL group. These findings further demonstrate that IVT-AFL is associated with clinically meaningful improvements in visual acuity and support prior evidence suggesting that earlier treatment with IVT-AFL should be recommended for patients with myopic CNV.