Session Title: Free Paper Session 11: Vascular Diseases & Diabetic Retinopathy III
Session Date/Time: Friday 08/09/2017 | 11:00-12:30
Paper Time: 11:12
Venue: Room 114
First Author: : R.Hamilton UK
Co Author(s): : R. Hamilton T. Lai H. Dai W. MacFadden
Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy approved for the treatment of visual impairment due to neovascular age-related macular degeneration, diabetic macular edema, branch and central retinal vein occlusion, and myopic choroidal neovascularization (mCNV). Although the efficacy and safety of ranibizumab has been well-established in many randomized clinical trials, there is less information on its use in real-world clinical settings. Here, we report the effectiveness and safety of ranibizumab in treatment-naïve mCNV patients enrolled in the LUMINOUS™ study with 1 year follow-up.
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 (neovascular age-related macular degeneration, diabetic macular edema, branch and central retinal vein occlusion, and mCNV), 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 12 month visual acuity (VA, Early Treatment Diabetic Retinopathy Study [ETDRS] letter score, primary treated eye), as well as injection and monitoring visit results for the mCNV treatment-naïve patient subgroup. The incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) for the total mCNV cohort is also presented.
Baseline data were available for 30,138 patients, of whom 297 had mCNV; this relatively low number of patients is due to recruitment for this disorder beginning later in the LUMINOUS study. At baseline, the mean (SD) age of mCNV treatment-naïve patients (n = 108) was 57.6 (15.6) years, 80.6% were female, 88.9% were Caucasian and 4.6% were Asian. Twelve month VA data were available for a total of 61 treatment-naïve patients. Mean (SD) baseline VA for these patients was 50.1 (20.5) letters. At Month 12, the mean (SD) VA was 59.6 (20.9) letters corresponding to a mean (SD) improvement in VA from baseline of +9.4 (18.0) letters. This gain in VA was achieved with a mean (SD) of 2.9 (1.6) ranibizumab injections and 7.4 (2.3) monitoring visits. The incidence of ocular SAEs and AEs across all mCNV patients (n = 297) was 1.0% and 10.1%, respectively, with non-ocular SAEs and AEs in this group occurring in 2.0% and 11.8% of patients.
Twelve months of ranibizumab treatment resulted in a robust 9.4 letter improvement in VA in treatment-naïve mCNV patients. This improvement in VA was achieved with a low mean number of injections and without any new safety signals. The treatment-naïve mCNV patients analyzed here 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. These results from the final analysis of the LUMINOUS study demonstrate the effectiveness and safety of ranibizumab for the treatment of mCNV in real-world clinical practice.