A matched cohort study comparing the effectiveness of ranibizumab monotherapy vs ranibizumab to aflibercept treatment switch in nAMD

Session Details

Session Title: Free Paper Session 9: AMD III

Session Date/Time: Friday 08/09/2017 | 08:00-09:30

Paper Time: 08:54

Venue: Room 117

First Author: : U.Chakravarthy UK

Co Author(s): :    V. Bezlyak   R. Griner   A. Skelly   A. Sagkriotis   D. Boyer   F. Milnes               

Abstract Details

Purpose:

Limited data exists on clinical outcomes in neovascular age-related macular degeneration (nAMD) in patients who were switched between licensed anti-vascular endothelial growth factor (anti-VEGF) treatments in real-world clinical practice. The objective of this study was to compare visual acuity (VA) outcomes between nAMD patients treated with ranibizumab monotherapy (RBZ) to patients switched to aflibercept (RBZ-AFL) from the first record of RBZ injection (index date) to Month 24 (M24).

Setting:

Electronic medical record (EMR) data were extracted from a panel of 55 Medical Retina Practices across the US and subsequently anonymized prior to analysis. Clinical measurements were recorded at routine patient visits.

Methods:

Eligibility criteria for inclusion in the dataset were persons aged ≥21 years with a diagnosis of nAMD, received ≥1 RBZ treatment between 01-Jan-2011 and 30-Mar-2016, had a valid VA reading on or within 30 days prior to the index date, ≥1 RBZ treatment during the follow-up period, and at least 180-days of follow-up. Eyes were excluded if a drug other than RBZ was used at the index date, were missing laterality information, switched to a drug other than AFL, or had a non-convertible VA record at baseline. When both eyes of a patient were eligible, the worse-seeing eye was selected. VA measurements were converted to a letter score. The primary endpoint was the change in VA letter score from index date to M24 for RBZ-AFL switched eyes compared with matched RBZ monotherapy eyes. Cohorts were matched on age, baseline VA, VA at Month 3, and duration of follow-up. The matching ratio was 1:2 where possible (RBZ-AFL vs RBZ), and 1:1 otherwise. Secondary outcomes were the rate of ophthalmologist visits and anti-VEGF injections during the 24 month of follow-up period and the pre-switch period duration.

Results:

1,534 RB eyes and 925 RBZ-AFL eyes met the eligibility criteria for inclusion, of which 1,294 RBZ eyes and 463 RBZ-AFL had a VA measure at M24. Mean (standard deviation (SD)) age (82.9 (7.7) vs 82.5 (7.9)) and mean VA (SD) at the index date in the study eye (53.1 (23.2) vs 54.1 (22.3) were comparable for RBZ and RBZ-AFL cohorts, respectively. The RBZ cohort had a higher proportion of females than the RBZ-AFL cohort (65.8% vs 60.5%). The adjusted least square (LS) mean (95% confidence interval (CI)) VA change from index to M24 was -1.9 (-2.84, -0.89) and -1.6 (-3.17, -0.06) letters for RBZ and RBZ-AFL, respectively, with an adjusted LS mean (95% CI) difference (RBZ-AFL minus RBZ) of -0.3 (-1.90, 1.39) letters between the cohorts. The adjusted annualized rates of ophthalmologist visits and anti-VEGF injections were significantly lower for RBZ eyes than for RBZ-AFL eyes (ophthalmologist visits/year: 8.2 vs 9.7, rate ratio (95% CI): 0.85 (0.82, 0.87); injection rate: 5.9 vs 8.1, rate ratio (95% CI): 0.73 (0.71, 0.75). The mean (SD) pre-switch period duration for RBZ-AFL eyes was 291 (158) days.

Conclusions:

Patients who remained on RBZ monotherapy had comparable VA outcomes to those switched to AFL during the two-year follow-up period, with the former receiving significantly fewer injections. These results indicate that switching from RBZ to AFL generally does not result in improved VA compared to RBZ monotherapy. Understanding the rationale behind the decision to switch licensed anti-VEGF treatments could shed light on unmet needs in patients with nAMD.

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