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RANIBIZUMAB VERSUS VERTEPORFIN PHOTODYNAMIC THERAPY IN ASIAN PATIENTS WITH MYOPIC CHOROIDAL NEOVASCULARIZATION: BRILLIANCE, a 12-Month, Randomized, Double-Masked Study

Chen, Youxin, MD*; Sharma, Tarun, MD†,‡; Li, Xiaorong, MD§; Song, Yanping, MD; Chang, Qing, MD, PhD**; Lin, Renxin, MSc††; Egger, Anna, PhD‡‡; Foo, Arthur, PhD§§; Gekkieva, Margarita, MD‡‡; Lai, Timothy Y. Y., MD, FRCOphth¶¶

doi: 10.1097/IAE.0000000000002292
Original Study: PDF Only

Purpose: To evaluate the efficacy and safety of 2 dosing regimens of ranibizumab 0.5 mg versus verteporfin photodynamic therapy in Asian patients with visual impairment due to myopic choroidal neovascularization.

Methods: Eligible patients (aged ≥18 years) were randomized 2:2:1 to Group I (n = 182; ranibizumab treatment guided by visual acuity stabilization criteria); Group II (n = 184; ranibizumab treatment guided by disease activity); or Group III (n = 91; verteporfin photodynamic therapy on Day 1; from Month 3, ranibizumab/verteporfin photodynamic therapy/both treatment guided by disease activity).

Results: The mean average best-corrected visual acuity change from baseline to Month 1 through Month 3 was significantly higher in Groups I/II versus Group III (Group I/II: +9.5/+9.8 letters vs. Group III: +4.5 letters; both P < 0.001). Group II was statistically noninferior to Group I for the mean average best-corrected visual acuity change from baseline to Month 1 through Month 6 (10.7 vs. 10.4 letters; P < 0.001). Over 12 months, the mean number of ranibizumab injections received by Groups I/II/III was 4.6/3.9/3.2.

Conclusion: In Asian patients, ranibizumab treatments demonstrated superior efficacy versus verteporfin photodynamic therapy at Month 3, and the beneficial treatment effects persisted at Month 12. Ranibizumab was well-tolerated and demonstrated a good safety profile.

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Ranibizumab 0.5 mg administered over 12 months was efficacious and well-tolerated in Asian patients with visual impairment due to myopic choroidal neovascularization. Ranibizumab treatment guided by visual acuity stabilization or disease activity criteria resulted in statistically superior efficacy compared with verteporfin photodynamic therapy.

*Department of Ophthalmology, Peking Union Medical College Hospital, Beijing, China;

Department of Ophthalmology, The Edward S. Harkness Eye Institute, Columbia University, New York, New York;

Department of Ophthalmology, Vision Research Foundation, Sankara Nethralaya, Chennai, Tamil Nadu, India;

§Tianjin Medical University Eye Hospital, Tianjin, China;

Department of Ophthalmology, Wuhan General Hospital of Chinese People's Liberation Army, Wuhan, China;

**Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai, China;

††Department of Ophthalmology, China Novartis Institutes for BioMedical Research Co, Ltd, Shanghai, China;

‡‡Department of Ophthalmology, Novartis Pharma AG, Basel, Switzerland;

§§Department of Ophthalmology, Novartis Asia Pacific Pharmaceuticals, Singapore, Singapore; and

¶¶Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Hong Kong SAR, China.

Reprint requests: Timothy Y. Y. Lai, MD, FRCOphth, Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong SAR, China; e-mail: tyylai@cuhk.edu.hk

The study was funded and managed by Novartis Pharma AG and is registered with www.clinicaltrials.gov (NCT01922102).

Data from this study were presented at the Retina China Congress, Shanghai, China, April 12–15, 2017; the 40th Annual Macula Society Meeting, Singapore, Singapore, June 7–10, 2017; the 17th European School for Advanced Studies in Ophthalmology (ESASO) Congress, Berlin, Germany, 29 June–1 July 2017; the 17th European Society of Retina Specialists (EURETINA), Barcelona, Spain, September 7–10, 2017; and the 33rd Asia-Pacific Academy of Ophthalmology (APAO) Congress, Hong Kong, China, 8–11 February, 2018.

Y. Chen, Lecture fees—Bayer Healthcare, Novartis, and Kanghong Pharmaceutical Co, Ltd, China. X. Li, Lecture fees—Bayer Healthcare, Novartis, and Konghong Pharmaceutical Co, Ltd, China. Y. Song, Lecture fees—Bayer Healthcare, Novartis, and Konghong Pharmaceutical Co, Ltd, China. Q. Chang, Lecture fees—Allergan, Bayer Healthcare, Konghong Pharmaceutical Co, Ltd, China, and Novartis Pharmaceuticals. R. Lin, Employee of China Novartis Institutes for BioMedical Research Co Ltd, Shanghai, China. A. Egger, Employee of Novartis Pharma AG, Basel, Switzerland. A. Foo, Employee of Novartis Asia Pacific Pharmaceuticals, Singapore, Singapore. M. Gekkieva, Employee of Novartis Pharma AG, Basel, Switzerland. T. Y. Y. Lai, Consultant—Allergan, Bayer Healthcare, Boehringer Ingelheim, Genentech, Novartis Pharmaceuticals, and Roche; Grants—Bayer Healthcare and Novartis Pharmaceuticals; Lecture fees—Allergan, Bausch & Lomb, Bayer Healthcare, and Novartis Pharmaceuticals. The remaining author has no financial/conflicting interests to disclose.

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