Format

Send to

Choose Destination
Eye (Lond). 2018 Dec;32(12):1871-1878. doi: 10.1038/s41433-018-0192-2. Epub 2018 Aug 29.

Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan.

Author information

1
Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan. k.ohno.oph@med.tmd.ac.jp.
2
Medical Scientific Expert, Medical Division, Novartis Pharma K.K., Tokyo, Japan.
3
Biostatistics, Japan Development, Novartis Pharma K.K., Tokyo, Japan.
4
Patient Safety Japan, Regulatory Office Japan, Novartis Pharma K.K., Tokyo, Japan.

Abstract

OBJECTIVES:

The aim of this study was to obtain real-world clinical data on the safety and efficacy of ranibizumab treatment for myopic choroidal neovascularization (CNV) due to pathologic myopia.

METHODS:

This was a prospective, observational, post-marketing surveillance study in ranibizumab-naive Japanese patients with myopic CNV. Patients who initiated ranibizumab treatment were registered and prospectively observed over 12 months. Safety endpoints were the incidence of ocular and non-ocular adverse drug reactions (ADRs) and serious adverse events (SAEs). The efficacy endpoint included the average change in best-corrected visual acuity (BCVA) in logarithm of the minimal angle of resolution (logMAR) units (logMAR BCVA) from baseline to the last observation.

RESULTS:

Three hundred and eighteen patients were included in the safety analysis population. Of these 79.9% were female and the mean age was 65.5 years. The incidences of SAEs and ADRs were 0.6 and 0.3%, respectively. A total of 268 patients (84.0%) completed the 12-month study period. The mean (±SD) and median number of ranibizumab injections were 2.0 ± 1.5 and 1.0 during the 12-month study period, respectively. The number of ranibizumab injections received was one in 52.2% of patients and less than or equal to three in 89.2%. The mean change in logMAR BCVA from baseline to month 12 was -0.193, and the mean logMAR BCVA improved from 0.517 to 0.319 between baseline and month 12.

CONCLUSIONS:

This study showed that ranibizumab is generally well tolerated, and that a minimum number of injections were necessary to produce a therapeutic effect in Japanese myopic CNV patients in a real-world setting.

PMID:
30158574
PMCID:
PMC6292850
DOI:
10.1038/s41433-018-0192-2
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Nature Publishing Group Icon for PubMed Central
Loading ...
Support Center