Abstract
Purpose :
Age-related macular degeneration (AMD) is the leading cause of severe, irreversible vision loss in developed countries and is more common with increasing age. To date, there have been few large prospective randomized clinical studies which have assessed the efficacy of a treat-and-extend (T&E) regimen compared with monthly dosing for the treatment of neovascular AMD. The purpose of this analysis was to compare the effectiveness of ranibizumab using a T&E regimen to once-monthly (OM) dosing in treatment-naïve neovascular AMD patients.
Methods :
This is a 24-month prospective, randomized (1:1), open-label, multicenter, post-authorization study conducted in Canada. Interim analysis describing baseline characteristics, visual acuity, and injection frequency over 24 months. Summary statistics including the mean and standard deviation for continuous variables and counts and percentages for categorical variables were produced. Between group differences were assessed with the one-sided independent Samples t-test for change in best corrected visual acuity (BCVA).
Results :
580 patients (T&E=287; OM=293) were included in the analysis; of these, 526 patients (T&E=268; OM=258) and 343 patients (T&E=175; OM=168) had 12-month and 24-month follow-up, respectively. Mean (SD) age was 78.8 (7.8) years, 60.3% were females, 94.3% were Caucasian, and 22.4% had a family history of AMD. No significant between-group differences were observed in baseline characteristics. Mean (SD) baseline BCVA was 58.7 (14.2) and 59.4 (13.5) for T&E and OM, respectively, and was comparable for both groups. At Month 12, after an average of 9.4 (T&E) and 11.8 (OM) injections, mean (SD) BCVA improvement was 8.4 (11.9) and 6.0 (11.9) (p=0.012) letters, respectively. At Month 24, after an average of 18.0 (T&E) and 23.6 (OM) injections, mean (SD) BCVA improvement was comparable between groups with 6.4 (14.7) and 7.0 (12.1) letters (p=0.336), respectively. In the T&E group, the proportion of patients extended by ≥8 weeks of treatment at 12 and 24 months was 69.3% and 70.9% and those extended to 12 weeks was 29.9% and 40.0%, respectively.
Conclusions :
The results showed that a T&E dosing regimen offers comparable BCVA improvement at 12 and 24 months, but with significantly fewer injections when compared to a monthly dosing regimen. No new safety findings.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.