Robyn Guymer1, Wayne Macfadden2, Sue Lacey2
Purpose: LUMINOUS was designed for long-term evaluation of ranibizumab in routine clinical practice across all approved indications. We describe baseline characteristics and 1-year outcomes of treatment-naïve patients from the global and Australian cohorts with nAMD recruited before March 2014.
Methods: Patients were treated according to the local ranibizumab label, and data were analyzed based on prior treatment status of the treated eye (treatment naïve, prior ranibizumab treatment, or other prior ocular treatment). We report the results on treatment-naïve patients only.
Results: A total of 17,656 patients with nAMD were recruited, including 1,694 patients from Australia. Respectively 4497 and 227 of those patients were treatment-naïve at baseline. Mean age (years) and gender of Australian patients (79.3; 44.1% male) were similar to the global group (75.0; 44.2% male). In the global/Australian cohorts, 68.8%/91.2% of patients were Caucasian. Pigment epithelium detachment/polypoidal choroidal vasculopathy were present in 41.6%/8.4% of global patients and 25.6%/3.1% of Australian patients. At baseline, for global/Australian cohorts, the mean visual acuity (VA, letters) was 49.9/52.9 and the mean central retinal thickness (CRT, µm) was 360.6/300.6. At 1 year, in global/Australian cohorts, the mean change in VA was 3.6/5.3 letters with a mean of 4.3/7.9 ranibizumab injections and 7.3/9.4 visits. No new safety events were reported.
Conclusions: Overall, compared to the global cohort, treatment-naïve patients from the Australian cohort had higher VA and lower CRT at baseline, and achieved better VA outcomes with a higher mean number of ranibizumab injections at 1-year. Safety findings were consistent with ranibizumab’s safety profile.
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