One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial

الملخص EN

P urpose.

To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients.

Methods.

In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment.

Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated.

The main outcome was the change in BCVA.

The noninferiority limit was 5 letters.

Results.

Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up.

Each group included 4 PCV patients.

The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (P=0.344).

There were no significant differences between two groups in the mean change of CRT (−159.3 μm vs.

−120.5 μm) at month 12.

The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group.

The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (P=0.066).

Conclusion.

One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients.

Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria.

This trial is registered with NCT02810808.