Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study

Abstract

Objective: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in treatment-naïve patients with branch retinal vein occlusion (BRVO) enrolled in the LUMINOUS™ study.

Study design: A 5-year, global, prospective, multicenter, observational, open-label study conducted in a clinical practice (real-world) setting at outpatient ophthalmology clinics that recruited 30,138 consenting adult patients from all approved indications for ranibizumab across 42 countries. Patients with BRVO were treated according to the local ranibizumab label of the participating countries. Mean change in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study letters from baseline to Year 1, treatment exposure during Year 1, and adverse events (AEs) over 5 years were assessed.

Results: Of the 1366 recruited BRVO patients, 405 were treatment-naïve at baseline with a mean (standard deviation [SD]) age of 67.9 (12.5) years, 57.5% were female, and 71.8% were White. At Year 1 (n = 189), the mean (SD) VA gain was 11.9 (17.66) letters from a baseline of 49.2 (±20.32) letters with a mean (SD) of 5.0 (2.34) injections. VA gains were higher in patients (n = 83) who received 6-9 injections (13.6 [20.16] letters) than in those who received 2-5 injections (n = 92, 11.7 [15.43] letters), or 1 injection (n = 14, 3.6 [13.72] letters). Patients with baseline VA <23 letters had numerically highest VA gains (n = 20, 31.1 [24.48] letters). Over 5 years, the rate of ocular/non-ocular AEs was 7.4%/9.1% and serious AEs was 0.3%/4.4% in treatment-naïve BRVO patients (n = 405).

Conclusions: One year results from the LUMINOUS real-world study showed a clinically meaningful VA improvement with ranibizumab in treatment-naïve patients with BRVO; numerically higher VA gains were achieved in patients who received more injections and those with poor baseline VA. No new safety signals were observed.

Trial registration: ClinicalTrials.gov NCT01318941.

Conflict of interest statement

Ian Pearce is a consultant for Alcon Pharma, Allergan, Bayer Healthcare, Novartis Pharmaceuticals, and Roche; receives lecture fees from Alcon Pharma, Allergan, Bayer Healthcare, Novartis Pharmaceuticals, and Roche. Andreas Clemens and Cornelia Dunger-Baldauf are employees and shareholders of Novartis Pharma AG, Basel, Switzerland. Michael H Brent receives research support from Novartis, Bayer, Roche and in advisory boards of Bayer, Novartis, and Roche. Lin Lu has nothing to disclose. Roberto Gallego-Pinazo is a consultant for Novartis and Roche, speaker for Bloss, Heidelberg Engineering, Indo, Novartis, Novo Nordisk, Roche, and have received grant support from Boehringer-Ingelheim, Novartis, Roche, and Thrombogenics. Angelo Maria Minnella is a consultant for Theà Laboratoire and receives travel and meeting grant from Allergan, Bayer Healthcare, Novartis Pharmaceuticals, and Theà Laboratoire. Catherine Creuzot-Garcher is a consultant for Allergan, Alcon, Bausch & Lomb, Bayer, Novartis, Roche, and Thea. Georg Spital reports personal fees from Allergan, Bayer, Heidelberg Engineering, Novartis, and Zeiss, outside the submitted work. Taiji Sakamoto is a consultant for Bausch & Lomb, Bayer Healthcare, Novartis Pharmaceuticals, Roche, Santen, and Senju; receives grants from Bayer Healthcare, Novartis Pharmaceuticals, Otsuka Pharmaceuticals, Santen and Senju; receives lecture fees from Bausch & Lomb, Bayer Healthcare, Novartis Pharmaceuticals, Santen, and Senju. Ian McAllister is an advisory board member for Bayer and Novartis. The aforementioned disclosures for all authors does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Mean change in VA from baseline at Month 12.

Primary treated eye set, defined as the number of evaluable patients with baseline and Month 12 data who have been in the study for at least 365 days. Syringe symbol denotes mean number of injections from baseline to Month 12. There were only 2 patients from India with baseline and Month 12 VA data who have been in the study for at least 365 days. Therefore the mean VA has not been shown for the patients from India. ETDRS, Early treatment diabetic retinopathy study; VA, visual acuity.

Fig 2. Number of injections over 1 year.

Primary treated eye set, defined as number of evaluable patients with baseline and Month 12 data who have been in the study for at least 365 days. Dashed line denotes mean number of injections from baseline to Month 12 in the Global population (n = 189). VA, visual acuity.

Fig 3

Mean change in VA from baseline at Year 1 by A. injection frequency, B. baseline VA category, and C. in patients who received loading and those who did not. Primary treated eye set, defined as the number of evaluable patients with baseline and Month 12 data who have been in the study for at least 365 days. Syringe symbol denotes mean number of injections from Baseline to Month 12. Loading dose is defined as having 3 ranibizumab injections within the first 100 days of the study. ETDRS, Early treatment diabetic retinopathy study; VA, visual acuity.