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The MYRROR study- detailed evaluation of visual outcomes following intravitreal aflibercept injection in patients with choroidal neovascularisation secondary to pathological myopia

Session Details

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): :                  

Abstract Details

Purpose:

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.

Setting:

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).

Methods:

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.

Results:

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.

Conclusions:

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.

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