Masayuki Ohnaka, Masahito Ohji, Annabelle A Okada, Yasuhiro Terano, Masato Kobayashi, Kanji Takahashi
Purpose: To evaluate 2 intravitreal a?ibercept (IVT- AFL) treat-and-extend (T&E) dosing regimens in Japanese patients with wet age-related macular degeneration (wAMD).
Methods: ALTAIR (NCT02305238) was a 96-week, randomised, open-label, Phase 4 study conducted at 40 sites across Japan. Patients received 3 monthly doses of IVT-AFL before randomisation (1:1) at Week 16 to IVT-AFL with a 2-week (IVT-AFL-2W) or 4-week (IVT-AFL-4W) adjustment. Primary end- point was mean change in best-corrected visual acu- ity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to Week 52. Other endpoints included the proportion of patients losing <15 ETDRS letters, mean change in central retinal thickness (CRT), and treatment-emergent adverse events (TEAEs) at Week 52. Results: 254 patients were included in safety ana- lyses and 246 patients were included in efftcacy analyses. Baseline BCVA was 54.8 (IVT-AFL-2W) and 55.3 (IVT-AFL-4W) ETDRS letters. Mean change in BCVA from baseline to Week 52 was 9.0 (IVT-AFL-2W) versus 8.4 (IVT-AFL-4W) ETDRS letters. Proportion of patients losing <15 ETDRS let- ters was 96.7% (IVT-AFL-2W) versus 95.9% (IVT- AFL-4W). Mean change in CRT was ?134.4 (IVT- AFL-2W) versus ?126.1 (IVT-AFL-4W) ?m. Mean number of injections was 7.2 (IVT-AFL-2W) and 6.9 (IVT-AFL-4W). Mean injection interval (Weeks 16?52) was 10.0 (IVT-AFL-2W) and 10.9 (IVT-AFL-4W). The most common ocular TEAEs were con- junctival haemorrhage (2.4%) and retinal pigment epithelial tear (2.4%) (IVT-AFL-2W) and conjuncti- val haemorrhage (5.7%) (IVT-AFL-4W). Conclusions: Both IVT-AFL T&E regimens improved visual and anatomical outcomes at Week 52 with extended dosing intervals in wAMD patients. Ocular TEAEs were consistent with the known safety proftle of IVT-AFL.12 months (CI 95%). BCVA is shown to improve at each follow-up except 1 month; improvement of 0.046 logMAR at 12 months is not statistically sig- niftcant (p=0.103). Conclusion: the null hypothesis that triamcinolone is not an effective management option in treatment resistant can be rejected. Triamcinolone can be considered a second line option in the instance of failure of monotherapy. This study hopes to con- tribute to a body of evidence that will generate a consensus for an algorithm of second and third line management options ensuring best practice is passed on to all patients suffering with macular degeneration.
COMPARISON OF RANIBIZUMAB AND AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATED FOLLOWING A ?TREAT AND EXTEND? PROTOCOL: EFFICACY VARIABLES FROM THE PRE-SPECIFIED 12- MONTH INTERIM ANALYSIS OF THE RIVAL STUDY