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Korean J Ophthalmol. 2019 Apr;33(2):150-166. doi: 10.3341/kjo.2018.0081.

Short-term Efficacy and Safety of Ranibizumab for Neovascular Age-related Macular Degeneration in the Real World: A Post-marketing Surveillance Study.

Woo SJ#1, Cho GE#2, Cho JH3,4.

Author information

1
Department of Ophthalmology, Seoul National University Bundang Hospital, Seongnam, Korea. sejoon1@snu.ac.kr.
2
Novartis Korea, Seoul, Korea.
3
Department of Ophthalmology, Seoul National University Bundang Hospital, Seongnam, Korea.
4
Hyemin Eye Hospital, Seoul, Korea.
#
Contributed equally

Abstract

PURPOSE:

To investigate the short-term efficacy and safety of ranibizumab in the routine clinical setting in patients with neovascular age-related macular degeneration and to analyze the associated factors for visual outcome.

METHODS:

This was a post-hoc analysis of a ranibizumab regulatory post-marketing surveillance study in which 4,136 patients were enrolled and followed for 12 weeks. Change in best-corrected visual acuity (BCVA), size of choroidal neovascularization, and the presence of hemorrhage and exudate were analyzed and the association between BCVA change and baseline characteristics were investigated. Data on ocular and systemic adverse events were collected.

RESULTS:

Mean BCVA improved significantly and mean BCVA change was the logarithm of the minimal angle of resolution 0.13 ± 0.01 (p < 0.001). A lower baseline BCVA and younger age were significant predictive factors for visual improvement or maintenance (≥0 lines). For greater visual acuity gain (≥3 lines), no treatment history, lower baseline BCVA, younger age, and classic-type choroidal neovascularization were significant predictive factors. No new safety signals were found.

CONCLUSIONS:

In this study, conducted in real-world clinical practice with a large number of neovascular age-related macular degeneration patients, visual and anatomical outcomes improved significantly after three monthly ranibizumab treatments. Treatment-naive patients had a higher chance of greater visual gain (≥3 lines) than non-naive patients.

KEYWORDS:

Age-related macular degeneration; Efficacy; Post marketing surveillance; Ranibizumab; Real-world evidence

PMID:
30977325
PMCID:
PMC6462474
DOI:
10.3341/kjo.2018.0081
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Se Joon Woo is a paid consultant of Samsung Bioepis Inc., Songdo, South Korea and is a co-founder of RetiMark, a bio-venture company in Seoul, South Korea. Ga Eun Cho is an employee of Novartis Korea, Seoul, South Korea. Novartis Korea sponsored the study and was involved in the study conception, design, protocol writing, study coordination, data analysis, data interpretation, manuscript writing, English editing and submission. Joon Hee Cho has nothing to declare.

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