Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:18
Venue: Room 111
First Author: : A.Koh SINGAPORE
Co Author(s): : K. Prajapati W. Macfadden P. Margaron
The LUMINOUS™ study (NCT01318941) was designed to evaluate long-term safety, effectiveness, and treatment patterns associated with ranibizumab 0.5 mg in routine clinical practice across all approved indications. Here we present the baseline characteristics and 1-year outcomes of ranibizumab treatment in treatment-naïve neovascular age-related macular degeneration [nAMD] patients of Asian descent with or without polypoidal choroidal vasculopathy (PCV), a frequent subtype in these patients, enrolled in the LUMINOUS study.
LUMINOUS is a recently completed, 5-year, prospective, observational, global study that recruited over 30,000 patients from 494 sites across 43 countries.
Consenting adult patients (aged ≥18 years), who were treatment-naïve, or were previously treated with ranibizumab or another ocular therapy, were recruited for all approved indications as per the local label. Patients with nAMD were categorized as PCV or non-PCV based on the presence or absence of lesions at baseline as assessed by the study investigator. Here, we report the baseline and 1-year visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letter score, primary treated eye), central retinal thickness (CRT; assessed by spectral domain optical coherence tomography), injection pattern, and safety results for the treatment-naïve nAMD patients of Asian descent with or without PCV.
Among the treatment-naïve nAMD patients of Asian descent in the LUMINOUS study, 421 had PCV and 1396 were non-PCV. At baseline, the mean age (standard deviation) of treatment-naïve PCV and non-PCV patients was 72.5 (9.56) and 71.8 (10.62) years, 67.5% and 59.8% were male, respectively. Treatment-naïve PCV and non-PCV patients had a mean VA of 54.9 and 46.3 ETDRS letters, and mean CRT was 361.3 µm and 389.6 µm, respectively at baseline. At 1 year, the mean VA change in treatment-naïve PCV and non-PCV patients was 6.3 ETDRS letters (baseline, 57.5 ETDRS letters; n=186) and 4.8 ETDRS letters (baseline, 51.8 ETDRS letters; n=483), respectively, and the mean CRT change was −102.5 µm (baseline, 375.5 µm; n=131) and −86.2 µm (baseline, 381.1 µm; n=305), respectively. The 1-year outcomes were achieved with a mean of 3.4 and 2.9 ranibizumab injections and 7.3 and 6.0 visits for PCV and non-PCV patients, respectively. In treatment-naïve PCV/non-PCV groups, retinal and vitreous haemhorrage were reported as adverse events (AEs) in 1 (0.238%)/4 (0.287%) patients and 1 (0.238%)/1 (0.072%) patients, respectively. The only case of vitreous haemhorrage in the non-PCV group was considered as serious AE. No new safety events were reported.
Real-world evidence confirms the benefits of ranibizumab across all patients with nAMD, with similar visual and anatomical outcomes observed in patients of Asian descent regardless of the PCV status at 1 year. These results were achieved with a similar number of injections and visits. The overall safety profile of ranibizumab was consistent with that reported in previous nAMD studies. No unexpected ocular or non-ocular AEs were reported in PCV or non-PCV groups.