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EXTEND III: Efficacy and safety of ranibizumab in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD

  • Medical Ophthalmology
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Abstract

Background

The purpose of this study was to investigate the efficacy and safety of intravitreal ranibizumab 0.5 mg in South Korean and Taiwanese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Methods

This was a 12-month, open-label, single-arm, multi-center, phase III study. Ninety-five patients (Taiwanese: 51; South Korean: 44) were included in the study. Key outcome measures assessed included: mean change in best-corrected visual acuity (BCVA) from baseline to months 4 (primary endpoint) and 12 (secondary endpoint); other secondary endpoints comprising categorized mean change in BCVA from baseline at month 4 and month 12, mean change in BCVA from baseline at month 4 and month 12 per baseline characteristics; and incidence of ocular and non-ocular adverse events and serious adverse events (SAEs) at month 12.

Results

The mean BCVA change improved significantly (p < 0.0001) from baseline to both month 4 (+9.3 letters) and month 12 (+10.1 letters). At month 12, the proportion of patients who gained ≥5, 10, or 15 letters from baseline was 75.8%, 54.7%, and 32.6% respectively. Total and CNV lesion area significantly decreased from baseline (p < 0.0001). About 57% of patients showed complete absence of fluorescein leakage at month 12. Mean change from baseline visual acuity scores also increased significantly over time for all subgroups. At month 12, ocular SAEs occurred in 2.1% of patients (out of which one patient [1.1%] experienced endophthalmitis) and 16.8% of patients experienced non-ocular SAEs. There were no deaths reported during the study.

Conclusions

Consistent with previous studies in Caucasian and Japanese populations, EXTEND III confirms that monthly intravitreal injections of ranibizumab 0.5 mg administered over 12 months is effective and well-tolerated in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD.

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Acknowledgements/Disclosures

Funding

Novartis Pharma AG, Switzerland sponsored the study and was involved in the study conception and design, protocol writing, study drug provision, study coordination, data collection, data analysis, and interpretation.

Disclosures

None of the authors have any financial interests to disclose.

Contributions of authors

All authors (Oh-Woong Kwon, Fenq Lih Lee, Hum Chung, Chi-Chun Lai, Shwu-Jiuan Sheu and Young-Hee Yoon) contributed to the conception, design, and conduct of the study; data collection, analysis, and interpretation; critical revision and final approval of the article.

Statement about conformity with author information

Institutional Review Board approval was granted by Research Ethics Committee of National Taiwan University Hospital, Institutional Review Board of Taipei Veterans General Hospital, Chang-Gung Memorial, Mackay Memorial Hospital, Kaohsiung Veterans General Hospital, Changhua Christian Hospital (Taiwan); Kyung Pook National University Hospital; Institutional Review Board of Pusan National University Hospital, Samsung Medical Center, Seoul National University Hospital, Asan Medical Center and Yonsei University College of Medicine Severance Hospital (South Korea). The study was conducted according to the ethical principles of the Declaration of Helsinki, 1964, and informed consent was obtained from each patient in writing before screening and any study-related procedure.

Other acknowledgements

The following principal investigators from the EXTEND III Study Group who contributed to the study are acknowledged: Lee-Jen Chen, San-Ni Chen, Hum Chung, Si-Yeoul Kim, Oh-Woong Kwon, Chi-Chun Lai, Fenq-Lih Lee, Boo-Sup Oum, Shwu-Jiuan Sheu, Se-Woong Kang, Chung-May Yang, and Young-Hee Yoon.

The authors also thank Anupama Shrinivasan and Aditi Gandhe (Medical Communications, Novartis Healthcare Pvt. Ltd, Hyderabad, India) for their medical writing, and Srividdya Agoram, Ruchika Srinivasan and Mohammed Najeeb Ashraf (Medical Communications, Novartis Healthcare Pvt. Ltd, Hyderabad, India) for revision and resubmission assistance with the manuscript.

Author information

Authors and Affiliations

  1. The Retina Center, Nune Eye Hospital, Seoul, Korea

    Oh-Woong Kwon

  2. Taipei Veterans General Hospital No. 201, Section 2, Shih-Pai Road, Taipei, ROC 112, Taiwan

    Fenq Lih Lee

  3. Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea

    Hum Chung

  4. Chang-Gung Memorial Hospital, Lin-Ko, Taiwan

    Chi-Chun Lai

  5. Kaohsiung Veterans General Hospital, Kaohsiung, National Yang-Ming University, Taipei, Taiwan

    Shwu-Jiuan Sheu

  6. Department of Ophthalmology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea

    Young-Hee Yoon

Authors
  1. Oh-Woong Kwon
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  2. Fenq Lih Lee
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  3. Hum Chung
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  4. Chi-Chun Lai
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  5. Shwu-Jiuan Sheu
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  6. Young-Hee Yoon
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on behalf of the EXTEND III study group

Corresponding author

Correspondence to Fenq Lih Lee.

Additional information

The authors have full control of all primary data, and agree to allow Graefe’s Archive for Clinical and Experimental Ophthalmology to review the data on request.

The study is registered with www.novctrd.com as CRFB002A2304.

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Kwon, OW., Lee, F.L., Chung, H. et al. EXTEND III: Efficacy and safety of ranibizumab in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD. Graefes Arch Clin Exp Ophthalmol 250, 1467–1476 (2012). https://doi.org/10.1007/s00417-012-1970-3

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  • DOI: https://doi.org/10.1007/s00417-012-1970-3

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