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.