Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:54
Venue: Room 111
First Author: : F.Holz GERMANY
Co Author(s): : E. Souied R. Tuli S. Lacey W. Macfadden
The use of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, for the treatment of neovascular age-related macular degeneration (nAMD) is supported by a wealth of randomized controlled trial data. Ranibizumab’s effectiveness has also been demonstrated in real-world practice. Here, we report on injections and change in visual acuity (VA) over 12 months in the LUMINOUS™ study, the largest clinical trial in medical retina.
LUMINOUS (NCT01318941) is a recently-completed, five-year, multi-centre, global, observational study designed to evaluate the long-term effectiveness, safety, and treatment patterns associated with ranibizumab in clinical practice across all licensed indications. This study recruited over 30,000 patients from 494 sites in 43 countries.
Consenting adult (≥18 years old) patients were recruited for all ranibizumab indications (nAMD, diabetic macular edema, branch and central retinal vein occlusion, and myopic choroidal neovascularization), as per the local label, including treatment-naïve patients and patients previously treated with ranibizumab or other ocular therapies. Patients were only excluded due to prior treatment if they had received systemic or ocular anti-VEGF therapy other than ranibizumab 90 or 30 days prior to recruitment, respectively, or were participating in other investigational studies. The Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice guidelines were adhered to, and approval was obtained from the Ethics Committee or Institutional Review Board at each participating centre. Analyses were conducted according to patient subgroups: treatment-naïve, prior ranibizumab treatment and other prior ocular treatment. Here, we report, for the treatment-naïve nAMD patient subgroup, the change in VA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter score, primary treated eye) over the first year of treatment, as well as the change in VA stratified by the number of injections patients received (<3, 3–6, and >6 injections). The incidence of ocular and non-ocular adverse events (AEs) and serious AEs (SAEs) for the total treatment-naïve nAMD cohort is also presented.
Baseline and one year VA data were available for 2,701 treatment-naïve nAMD patients. At baseline, the mean (SD) age was 75.9 (9.7) years, 58.4% were female, 78.4% were Caucasian and 18.5% were Asian. VA gains at year 1 in patients receiving <3, 3–6, and >6 injections were 2.1 letters (n = 372), 3.6 letters (n = 1,499), and 4.3 letters (n = 830), from baseline letter scores of 45.0, 52.5, and 54.9, respectively. The mean (SD) change in VA at 1 year for all treatment-naïve nAMD patients in all regions was 3.6 (16.2) letters from a baseline of 52.2 (20.8) letters. These gains in VA were achieved with a mean (SD) of 5.3 (2.7) ranibizumab injections, and a mean (SD) of 9.3 (3.3) monitoring visits. The incidence of ocular SAEs and AEs across all treatment-naïve nAMD patients in the study (n = 6,241) was 0.9% and 8.2%, respectively, with non-ocular SAEs and AEs in this group occurring in 7.4% and 12.8% of patients, respectively.
This analysis from the LUMINOUS study further confirms the effectiveness of ranibizumab in treatment-naïve nAMD, and also demonstrates a relationship between improvement in VA and the number of ranibizumab injections each patient received. These treatment-naïve nAMD patients had more diverse patient and ocular baseline characteristics than normally allowed in clinical trials, and were treated in real-world clinical practice across many different healthcare systems. Further follow-up analyses of the LUMINOUS nAMD cohort will provide additional long-term evidence of ranibizumab’s value in real-world clinical practice.