Session Title: Free Paper Session 11: Vascular Diseases & Diabetic Retinopathy III
Session Date/Time: Friday 08/09/2017 | 11:00-12:30
Paper Time: 11:30
Venue: Room 114
First Author: : I.Pearce UK
Co Author(s): : R. Tadayoni E. Zangvil W. Macfadden
Ranibizumab is approved for the treatment of macular edema following retinal vein occlusion (RVO) but limited data are available on its use in real-world settings. LUMINOUS™ (NCT01318941), the largest prospective observational study in the medical retina field, was designed to evaluate the long-term safety, effectiveness, and treatment patterns associated with ranibizumab 0.5 mg treatment in routine clinical practice across all approved indications. We present the effectiveness and safety of ranibizumab treatment in patients with RVO (branch RVO [BRVO] or central RVO [CRVO]) from the final analysis of the LUMINOUS study.
LUMINOUS (initiated in March 2011) is a recently completed, 5-year, global, multicentre, observational, non-interventional, open-label study, that recruited over 30,000 patients from 494 sites in 43 countries. All patients were treated as per the local practice of the participating centres.
Consenting adult (≥18 years) patients were recruited for all ranibizumab indications (neovascular age-related macular degeneration, diabetic macular edema, RVO, 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 RVO 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 RVO cohort is also presented.
One-year VA data are available for 250 treatment-naïve RVO patients (BRVO: 132; CRVO: 118). At baseline, the mean age of treatment-naïve BRVO/CRVO patients was 68.1/69.8 years, 41.7%/53.4% of patients were male and 75.0%/80.5% were Caucasian, respectively. VA gains at 1 year in the treatment-naïve BRVO group receiving <3, 3–6, and >6 injections were +5.3 letters (n=15), +10.6 letters (n=73), and +14.9 letters (n=44), from baseline letter scores of 45.7, 47.9, and 51.3, respectively. In patients with CRVO, results were +5.4 letters (n=16), +11.4 letters (n=55), and +10.6 letters (n=47), from baseline letter scores of 43.4, 40.4, and 41.7, respectively. The average mean VA change at 1 year across all injection categories from the entire global treatment-naïve group was +11.4 letters from a baseline of 48.8 letters in BRVO patients and +10.3 letters from a baseline of 41.3 letters in CRVO patients. These VA gains were achieved with 5.4/5.6 mean ranibizumab injections and 9.2/9.1 mean visits in BRVO/CRVO treatment-naïve patients, respectively. The rate of ocular/non-ocular SAEs and AEs reported across all treatment-naïve BRVO patients (n=405) was 0.25%/4.44% and 7.41%/9.14% and that in CRVO patients (n=327) was 1.22%/6.73% and 11.32%/8.56%, respectively.
The treatment-naïve RVO patients in the LUMINOUS study had more diverse baseline characteristics than those in randomized clinical trials and were treated in real-world clinical practice across many different healthcare systems. Ranibizumab treatment in treatment-naïve patients with RVO generally resulted in an improvement in VA at 1 year. Greater average VA gains were noted in patients with 3–6 injections, with the best results seen in patients who received at least 6 injections. No new safety findings were identified. These results from the final analysis of LUMINOUS demonstrate the effectiveness and safety of ranibizumab for the treatment of RVO (BRVO and CRVO) in the real-world clinical practice.