Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study

Abstract

Purpose: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study.

Patients and methods: LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167).

Results: At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and ≥5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received ≤6 and >6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively.

Conclusions: Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving ≥6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.

Trial registration: ClinicalTrials.gov NCT01318941.

Conflict of interest statement

Prof. Frank G Holz is a consultant for Acucela, Alcon, Bayer, Boehringer-Ingelheim, Galimedix, Genentech, Heidelberg Engineering, Khanghong, Lin-Bioscience, Novartis, Oxurion, Roche, Zeiss; receives grants from Bayer, Centervue, Genentech/Roche, Heidelberg Engineering, Novartis, and Zeiss. Prof. Angelo M Minnella is a consultant for Theà Laboratoire; receives grants (travel and meeting) from Allergan, Bayer Healthcare, Novartis Pharmaceutical, Theà Laboratoire. Dr. Raman Tuli is a member of advisory boards in Bayer, Novartis; receives grants from Apelis, Novartis, Roche. Prof. Pradeepa Yoganathan receives honoraria from Alimera Sciences, Genentech, and Knight Therapeutics including non-financial support from Bayer and Novartis. Dr. Soumil Parikh is an employee of Novartis Pharma AG, Basel, Switzerland. Dr. Robin Hamilton is a consultant for Allergan, Bayer Healthcare, Novartis Pharmaceuticals, and Roche; receives grants from Bayer Healthcare, Novartis Pharmaceuticals and Roche; receives lecture fees from Allergan, Bayer Healthcare, Novartis Pharmaceuticals and Roche. We state that this does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1

A. Proportion of nAMD patients by treatment status group (%). N, total number of patients; nAMD, neovascular age-related macular degeneration. B. Duration of prior ranibizumab treatment (N = 16,167). N, total number of patients; n, number of patients; nAMD, neovascular age-related macular degeneration.

Fig 2. Country-specific enrollment of prior ranibizumab-treated patients with nAMD.

Pop-out boxes only displayed for top 10 countries with nAMD patients treated with ranibizumab prior to entering LUMINOUS. n, number of patients; nAMD, neovascular age-related macular degeneration; UK, United Kingdom.

Fig 3. VA outcomes at Year 1 stratified by duration of treatment.

Primary treated eye set; n, number of patients with evaluable patients with baseline and Month 12 data; ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.

Fig 4

A. Overall VA gains at Year 1 in patients who received prior ranibizumab treatment for <1 year. N, number of patients with evaluable baseline and 1-year data; VA, visual acuity. B. Overall VA letters lost at Year 1 in patients who received prior ranibizumab treatment for <1 year. *Includes patients with 0 letters loss. †At 1-year, vision was largely maintained in almost half (47.1%) of patients treated with ranibizumab for up to 1 year before entering LUMINOUS. N, number of patients with evaluable baseline and 1-year data; VA, visual acuity.

Fig 5. VA outcomes at 1 year in patients who received prior ranibizumab treatment for

n, number of patients with evaluable patients with baseline and Month 12 data; ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.