LONG-TERM FOLLOW-UP OF RANIBIZUMAB TREATED PATIENTS WITH MYOPIC CHOROIDAL NEOVASCULARIZATION FROM THE RADIANCE CLINICAL TRIAL IN FOUR EAST ASIAN COUNTRIES
Author(s)
Skelly A1, Lara N2, Pedros M2, Macfadden W3
1Novartis Ireland Limited, Dublin, Ireland, 2IMS Health, Barcelona, Spain, 3Novartis Pharma AG, Basel, Switzerland
OBJECTIVES: The aim of the study was to assess long-term effectiveness and safety of ranibizumab in East-Asian patients with visual impairment due to myopic choroidal neovascularization (mCNV). METHODS: An observational study with a 36-month retrospective multicenter chart review was conducted in a cohort of East-Asian patients with mCNV who completed the RADIANCE study (NCT01217944), had at least one follow-up visit after RADIANCE trial participation and whose medical records were available. The study primary outcome was mean change in Best Corrected Visual Acuity (BCVA) from the baseline visit of the RADIANCE trial (Month 0) to each follow-up visit during the post-RADIANCE observation period (Month 13–48). Baseline data were obtained from the trial database and follow-up data by reviewing patients’ clinical charts. RESULTS: Forty-one patients were included in this study, 80.5% were females, mean (±standard deviation, SD) age was 55.1 (±13.5) years. Thirty-six, 32 and 15 patients had 24, 36 and 48 months of follow-up, respectively.Mean (±SD) BCVA at baseline was 56.5 (±12.1) letters. Mean BCVA change at 12, 24, 36 and 48 months was +14.3 (±11.37)[p<0.0001], +10.42 (±22.32)[p=0.014], +7.40 (±24.21)[p=0.105], +16.25 (±17.72) [p=0.003] letters, respectively. At 12 months, 47.5% of patients gained ≥15 letters, at 24, 36 and 48 months the percentages were 45.2%, 46.7% and 56.3%.During the 36-month follow-up period, 7 patients (17.1%) received additional anti-VEGF treatment; the mean (±SD) number of administrations was 5.00 (±5.94). Five patients (12.2%) experienced an ocular AE, none of them were reported to be serious or with suspected relationship with the mCNV treatment. CONCLUSIONS: BCVA gained at the end of the RADIANCE study was sustained over an additional 36 months of follow-up in East-Asian patients, during which time most patients did not require any further anti-VEGF treatment and no new safety concerns were observed.
Conference/Value in Health Info
2016-09, ISPOR Asia Pacific 2016, Singapore
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PSS1
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Sensory System Disorders